FROM: U.S. FOOD AND DRUG ADMINISTRATION
Supera Peripheral Stent System – P120020
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Supera Peripheral Stent System
PMA Applicant: IDEV Technologies
Address: 253 Medical Center Blvd., Webster, TX 77598
Approval Date: March 28, 2014
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf12/P120020a.pdf
What is it? The Supera Peripheral Stent System is used to re-open narrowed (stenotic) regions of the superficial femoral and proximal popliteal arteries which supply blood to the legs. It consists of two components, the stent and the delivery system. The stent is a small woven tube made of two metals (nickel and titanium). The stent is mounted within the delivery catheter; a long, thin, tube-like device used to deliver the stent into the artery.
How does it work?
A catheter with a deflated balloon at its tip is inserted into a blood vessel in the groin and advanced within the vessel to the narrowed section of the superficial femoral or proximal popliteal artery.
The balloon is inflated within the narrowed artery to open the artery by pushing the plaque against the artery wall (balloon angioplasty).
The angioplasty balloon and its catheter are removed. The Supera Peripheral Stent System is advanced through the same vessel and positioned within the expanded artery.
The stent is then released (deployed). The stent opens automatically over the blockage as it is released from the delivery system.
The stent placement increases blood flow to the legs by holding the artery wall open.
Once the stent is deployed, the stent delivery catheter is removed.
The stent remains permanently implanted in the superficial femoral or proximal popliteal artery and acts as a support for the newly opened section of the vessel.
When is it used? The Supera Peripheral Stent System is used to treat patients with narrowing of a superficial femoral or proximal popliteal arteries caused by atherosclerosis, the collection of fatty substances such as cholesterol that forms “plaque” along the lining of the arteries. This narrowing may limit blood flow to the legs, leading to pain when walking.
What will it accomplish? The inside lining of the artery will grow over the stent approximately 8 weeks after it is implanted. Once in place, the stent acts as a scaffold to:
Hold open the narrowed superficial femoral or proximal popliteal artery, and
Improve blood flow to the legs.
When should it not be used? Use of the Supera Peripheral Stent System is contraindicated in the following cases:
When a patient has a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system.
When a patient cannot receive specific blood thinning medications, such as aspirin or Coumadin, among others.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.
Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts
Monday, April 21, 2014
Thursday, April 17, 2014
FDA APPROVES TANZEUM FOR TREATMENT OF TYPE 2 DIABETES
FROM: U.S. FOOD AND DRUG ADMINISTRATION
FDA NEWS RELEASE
For Immediate Release: April 15, 2014
Consumer Inquiries: 888-INFO-FDA
FDA approves Tanzeum to treat type 2 diabetes
The U.S. Food and Drug Administration today approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.
Type 2 diabetes affects approximately 24 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.
"Tanzeum is a new treatment option for the millions of Americans living with type 2 diabetes," said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “It can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes.”
Tanzeum is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels. The drug’s safety and effectiveness were evaluated in eight clinical trials involving more than 2,000 patients with type 2 diabetes. Patients participating in the trials showed an improvement in their HbA1c level (hemoglobin A1c or glycosylated hemoglobin, a measure of blood sugar control).
Tanzeum has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies, including metformin, glimepiride, pioglitazone, and insulin. Tanzeum should not be used to treat people with type 1 diabetes; those who have increased ketones in their blood or urine (diabetic ketoacidosis); or as first-line therapy for patients who can’t be managed with diet and exercise.
Tanzeum has a Boxed Warning to warn that tumors of the thyroid gland (thyroid C-cell tumors) have been observed in rodent studies with some GLP-1 receptor agonists, but that it is unknown whether Tanzeum causes thyroid C-cell tumors, including a type of thyroid cancer called medullary thyroid carcinoma (MTC), in humans. Tanzeum should not be used in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (a disease where patients have tumors in more than one gland in their body and that predisposes them to MTC).
The FDA is requiring the following post-marketing studies for Tanzeum:
The FDA is requiring the following post-marketing studies for Tanzeum:
- a clinical trial to evaluate dosing, efficacy, and safety in pediatric patients;
- a medullary thyroid carcinoma (MTC) case registry of at least 15 years duration to identify any increase in MTC incidence related to Tanzeum;
- a cardiovascular outcomes trial (CVOT) to evaluate the cardiovascular risk of Tanzeum in patients with high baseline risk of cardiovascular disease.
In clinical trials, the most common side effects observed in patients treated with Tanzeum were diarrhea, nausea, and injection site reactions.
The FDA approved Tanzeum with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a communication plan to inform health care providers about the serious risks associated with Tanzeum.
The FDA approved Tanzeum with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a communication plan to inform health care providers about the serious risks associated with Tanzeum.
Tanzeum is manufactured by GlaxoSmithKline, L.L.C., Wilmington, Del.
For more information:
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Tuesday, March 25, 2014
OTEZLA APPROVED BY FDA TO TREAT ADULT ACTIVE PSORIATIC ARTHRITIS
FDA NEWS RELEASE
For Immediate Release: March 21, 2014
Media Inquiries: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
Media Inquiries: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA approves Otezla to treat psoriatic arthritis
The U.S. Food and Drug Administration today approved Otezla (apremilast) to treat adults with active psoriatic arthritis (PsA).
PsA is a form of arthritis that affects some people with psoriasis. Most people develop psoriasis first and are later diagnosed with PsA. Joint pain, stiffness and swelling are the main signs and symptoms of PsA. Currently approved treatments for PsA include corticosteroids, tumor necrosis factor (TNF) blockers, and an interleukin-12/interleukin-23 inhibitor.
“Relief of pain and inflammation and improving physical function are important treatment goals for patients with active psoriatic arthritis,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “Otezla provides a new treatment option for patients suffering from this disease.”
The safety and effectiveness of Otezla, an inhibitor of phosphodieasterase-4 (PDE-4), were evaluated in three clinical trials involving 1,493 patients with active PsA. Patients treated with Otezla showed improvement in signs and symptoms of PsA, including tender and swollen joints and physical function, compared to placebo.
Patients treated with Otezla should have their weight monitored regularly by a healthcare professional. If unexplained or clinically significant weight loss occurs, the weight loss should be evaluated and discontinuation of treatment should be considered. Treatment with Otezla was also associated with an increase in reports of depression compared to placebo.
The FDA is requiring a pregnancy exposure registry as a post-marketing requirement to assess the risks to pregnant women related to Otezla exposure.
In clinical trials, the most common side effects observed in patients treated with Otezla were diarrhea, nausea, and headache.
In clinical trials, the most common side effects observed in patients treated with Otezla were diarrhea, nausea, and headache.
Tuesday, March 4, 2014
FDA RAISES AWARENESS OF RARE DISEASE THERAPIES AND ORPHAN PRODUCTS DEVELOPMENT
FROM: U.S. FOOD AND DRUG ADMINISTRATION
FDA Speeds Innovation in Rare Disease Therapies
Patients often need advocates, and that can be especially true for people with a rare disease, who have unique problems and may have little or no support or available treatment.
The Food and Drug Administration (FDA) is committed to helping patients and advancing rare disease therapies through the development of "orphan" medical products, including drugs, biologic (such as a protein, vaccine or blood product), and devices used to treat a rare disease or condition. The Orphan Drug Act defines a disease as rare if fewer than 200,000 people in the United States have it.
FDA's Office of Orphan Products Development (OOPD), in collaboration with the Center for Drug Evaluation and Research (CDER), is launching web-based educational resources for patients and industry on FDA-related rare disease topics. The first of these resources will debut Feb. 28, 2014, in recognition of International Rare Disease Day, and will cover topics that include how to interact with the agency and how to access therapies that are currently being studied.
Rare Disease Day, which is commemorated on the last day in February, is a global campaign to raise awareness of the more than 250 million people worldwide who suffer from rare diseases. About 7,000 rare diseases have been identified around the world; some have familiar names, such as cystic fibrosis and Lou Gehrig's disease, but many don't. Thirty million Americans have rare diseases, which can be chronic, progressive, debilitating, disabling, severe or life-threatening. About 80 percent of rare diseases are genetic, and about half of all rare diseases affect children.
FDA's Office of Orphan Products Development
FDA is in a unique position to help those who suffer from rare diseases by offering several important incentives to promote the development of products for rare diseases, including:
granting orphan drug designation for drugs and biologics, which encourages companies to develop a product by giving them financial and other incentives;
providing grant funds to further the clinical development of drugs, biologics, medical devices and medical foods for the treatment of rare diseases;
granting humanitarian use device (HUD) designation for medical devices for rare diseases, which makes these products eligible to enter the market via a separate marketing pathway known as the Humanitarian Device Exemption (HDE) Pathway; and providing grants to fund consortia to promote the development of pediatric devices, many of which are used to treat and diagnose rare diseases.
Gayatri R. Rao, M.D., J.D., director of OOPD, says 2013 was a record year for her office. The number of requests under FDA's Orphan Drug Designation Program rose about 18% in 2013 over 2012. FDA received nearly 450 orphan-drug designation requests and designated 258 promising orphan drugs, a 40% increase over 2012, says Rao.
"While many factors may be contributing to the growth of orphan drug development, patients are continuing to drive the push for innovation and treatments," she says.
In 2013, FDA approved 33 drugs for treating rare diseases. Since 1983, FDA has approved more than 450 drugs and biologic products for rare diseases. In the decade prior to the Orphan Drug Act, fewer than 10 treatments had been developed by industry for rare diseases.
"Last year, FDA funded 15 new orphan products grants for about $14 million, all supporting clinical research in rare diseases," says Rao. "Many of the studies that we have funded have supported the approval of orphan drugs and devices for rare disease patients."
On the device side, in 2013, FDA designated 16 medical devices for the treatment or diagnosis of rare diseases and approved two under the HDE pathway.
In addition, based on feedback from stakeholders, OOPD revamped its Pediatric Device Consortia (PDC) Grant Program.
"Now we focus more heavily on a consortium's ability to provide more holistic advice on device development," Rao says. "To bring a device to market, you need engineers, scientists, clinicians, business people and regulatory people collaborating for success."
Consortia advise on all sorts of devices through various stages of development, from the prototype stage through animal testing, clinical testing and commercialization. OOPD received 14 PDC applications last year and funded half of them.
In addition to these incentive programs, last year, OOPD, in conjunction with CDER and FDA's Center for Biologics Evaluation and Research (CBER), began administering the new Rare Pediatric Disease Priority Review Voucher Program to promote the development of new drugs and biologics for the prevention and treatment of rare pediatric diseases. In 2013, FDA received five requests for designation as a "rare pediatric disease" and designated three. In 2014, FDA awarded the first voucher under this program for the development of Vivizim to treat patients with a rare congenital enzyme disorder called Morquio A syndrome.
FDA Speeds Innovation in Rare Disease Therapies
Patients often need advocates, and that can be especially true for people with a rare disease, who have unique problems and may have little or no support or available treatment.
The Food and Drug Administration (FDA) is committed to helping patients and advancing rare disease therapies through the development of "orphan" medical products, including drugs, biologic (such as a protein, vaccine or blood product), and devices used to treat a rare disease or condition. The Orphan Drug Act defines a disease as rare if fewer than 200,000 people in the United States have it.
FDA's Office of Orphan Products Development (OOPD), in collaboration with the Center for Drug Evaluation and Research (CDER), is launching web-based educational resources for patients and industry on FDA-related rare disease topics. The first of these resources will debut Feb. 28, 2014, in recognition of International Rare Disease Day, and will cover topics that include how to interact with the agency and how to access therapies that are currently being studied.
Rare Disease Day, which is commemorated on the last day in February, is a global campaign to raise awareness of the more than 250 million people worldwide who suffer from rare diseases. About 7,000 rare diseases have been identified around the world; some have familiar names, such as cystic fibrosis and Lou Gehrig's disease, but many don't. Thirty million Americans have rare diseases, which can be chronic, progressive, debilitating, disabling, severe or life-threatening. About 80 percent of rare diseases are genetic, and about half of all rare diseases affect children.
FDA's Office of Orphan Products Development
FDA is in a unique position to help those who suffer from rare diseases by offering several important incentives to promote the development of products for rare diseases, including:
granting orphan drug designation for drugs and biologics, which encourages companies to develop a product by giving them financial and other incentives;
providing grant funds to further the clinical development of drugs, biologics, medical devices and medical foods for the treatment of rare diseases;
granting humanitarian use device (HUD) designation for medical devices for rare diseases, which makes these products eligible to enter the market via a separate marketing pathway known as the Humanitarian Device Exemption (HDE) Pathway; and providing grants to fund consortia to promote the development of pediatric devices, many of which are used to treat and diagnose rare diseases.
Gayatri R. Rao, M.D., J.D., director of OOPD, says 2013 was a record year for her office. The number of requests under FDA's Orphan Drug Designation Program rose about 18% in 2013 over 2012. FDA received nearly 450 orphan-drug designation requests and designated 258 promising orphan drugs, a 40% increase over 2012, says Rao.
"While many factors may be contributing to the growth of orphan drug development, patients are continuing to drive the push for innovation and treatments," she says.
In 2013, FDA approved 33 drugs for treating rare diseases. Since 1983, FDA has approved more than 450 drugs and biologic products for rare diseases. In the decade prior to the Orphan Drug Act, fewer than 10 treatments had been developed by industry for rare diseases.
"Last year, FDA funded 15 new orphan products grants for about $14 million, all supporting clinical research in rare diseases," says Rao. "Many of the studies that we have funded have supported the approval of orphan drugs and devices for rare disease patients."
On the device side, in 2013, FDA designated 16 medical devices for the treatment or diagnosis of rare diseases and approved two under the HDE pathway.
In addition, based on feedback from stakeholders, OOPD revamped its Pediatric Device Consortia (PDC) Grant Program.
"Now we focus more heavily on a consortium's ability to provide more holistic advice on device development," Rao says. "To bring a device to market, you need engineers, scientists, clinicians, business people and regulatory people collaborating for success."
Consortia advise on all sorts of devices through various stages of development, from the prototype stage through animal testing, clinical testing and commercialization. OOPD received 14 PDC applications last year and funded half of them.
In addition to these incentive programs, last year, OOPD, in conjunction with CDER and FDA's Center for Biologics Evaluation and Research (CBER), began administering the new Rare Pediatric Disease Priority Review Voucher Program to promote the development of new drugs and biologics for the prevention and treatment of rare pediatric diseases. In 2013, FDA received five requests for designation as a "rare pediatric disease" and designated three. In 2014, FDA awarded the first voucher under this program for the development of Vivizim to treat patients with a rare congenital enzyme disorder called Morquio A syndrome.
Sunday, February 23, 2014
$193.7 MILLION TO BE PAID BY DRUG COMPANIES TO RESOLVE UNAPPROVED MARKETING
FROM: U.S. JUSTICE DEPARTMENT
Friday, February 21, 2014
Endo Pharmaceuticals and Endo Health Solutions to Pay $192.7 Million to Resolve Criminal and Civil Liability Relating to Marketing of Prescription Drug Lidoderm for Unapproved Uses
Pharmaceutical company Endo Health Solutions Inc. and its subsidiary Endo Pharmaceuticals Inc. (Endo) have agreed to pay $192.7 million to resolve criminal and civil liability arising from Endo’s marketing of the prescription drug Lidoderm for uses not approved as safe and effective by the Food and Drug Administration (FDA), the Justice Department announced today. The resolution includes a deferred prosecution agreement and forfeiture totaling $20.8 million and civil false claims settlements with the federal government and the states and the District of Columbia totaling $171.9 million. Endo Pharmaceuticals Inc. is a Delaware corporation headquartered in Malvern, Pa.
“FDA’s drug approval process is designed to ensure that companies market their products for uses that are proven to be safe and effective,” said Assistant Attorney General for the Justice Department’s Civil Division Stuart F. Delery. “We will hold accountable those who circumvent that process in pursuit of financial gain.”
In a criminal information filed today in the Northern District of New York, the government charged that, between 2002 and 2006, Endo Pharmaceuticals Inc. introduced into interstate commerce Lidoderm that was misbranded under the Federal Food, Drug and Cosmetic Act (FDCA). The FDCA requires a company, such as Endo Pharmaceuticals Inc., to specify the intended uses of a product in its new drug application to the FDA. Once approved, a drug may not be introduced into interstate commerce for unapproved or “off-label” uses until the company receives FDA approval for the new intended uses. During the period of 2002 to 2006, Lidoderm was approved by the FDA only for the relief of pain associated with post-herpetic neuralgia (PHN), a complication of shingles. The information alleges that, during the relevant time period, the Lidoderm distributed nationwide by Endo Pharmaceuticals Inc. was misbranded because its labeling lacked adequate directions for use in the treatment of non-PHN related pain, including low back pain, diabetic neuropathy and carpal tunnel syndrome. These uses were intended by Endo Pharmaceuticals Inc. but never approved by the FDA. The information further alleges that certain Endo Pharmaceuticals Inc. sales managers provided instruction to certain sales representatives concerning how to expand sales conversations with doctors beyond PHN and encouraged promotion of Lidoderm in workers’ compensation clinics.
In a deferred prosecution agreement to resolve the charge, Endo Pharmaceuticals Inc. admitted that it intended that Lidoderm be used for unapproved indications and that it promoted Lidoderm to health care providers for those unapproved indications. Under the terms of the deferred prosecution agreement, Endo Pharmaceuticals Inc. will pay a total of $20.8 million in monetary penalties and forfeiture. Endo Pharmaceuticals Inc. further agreed to implement and maintain a number of enhanced compliance measures, including making publicly available the results of certain clinical trials and requiring an annual review and certification of its compliance efforts by the Chief Executive Officer of its parent company, Endo Health Solutions. The deferred prosecution agreement will not be final until accepted by the U.S. District Court for the Northern District of New York.
“The safety and efficacy of drugs must be shown by science, not sales pitches,” said U.S. Attorney for the Northern District of New York Richard S. Hartunian. “Drugs marketed for intended uses not approved by the FDA are misbranded because their labeling lacks adequate directions for those uses. This settlement emphasizes that public health is protected by labeling based on product performance, rather than profitability, and promotes enhanced efforts to ensure compliance with all requirements.”
In addition, Endo agreed to settle its potential civil liability in connection with its marketing of Lidoderm. The government alleged that, from March 1999 through December 2007, Endo caused false claims to be submitted to federal health care programs, including Medicaid, a jointly funded federal and state program, by promoting Lidoderm for unapproved uses, some of which were not medically accepted indications and, therefore, were not covered by the federal health care programs. Of the $171.9 million Endo has agreed to pay to resolve these civil claims, Endo will pay $137.7 million to the federal government and $34.2 million to the states and the District of Columbia.
“Off-label marketing can undermine the doctor-patient relationship and adversely influence the clear and honest judgment of doctors that their patients rely on and trust,” said U.S. Attorney for the Eastern District of Pennsylvania Zane D. Memeger. “Pharmaceutical companies have a legal obligation to promote their drugs for only FDA-approved uses. This obligation takes precedence over the company’s bottom line.”
“The settlement announced today demonstrates the government’s continued scrutiny of pharmaceutical companies that interfere with FDA’s mission of ensuring that drugs are safe and effective for the American public,” said Special Agent in Charge of the FDA’s Office of Criminal Investigations’ New York Field Office Mark Dragonetti. “We will continue to work with our law enforcement partners to investigate and prosecute pharmaceutical companies that disregard the drug approval process and jeopardize the public health by engaging in the nationwide distribution of misbranded products.”
“Endo Pharmaceutical enriched themselves at the expense of the public,” said Special Agent in Charge Andrew W. Vale of the Albany Division of the Federal Bureau of Investigation. “Patients will search for drug therapies to assist in pain management, and they deserve the right to drugs approved for such use. The FBI will continue to work with our federal partners to investigate companies such as Endo Pharmaceuticals to ensure patients are safe.”
Also as part of the settlement, Endo Pharmaceuticals Inc. has agreed to enter into a Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General that requires Endo to implement measures designed to avoid or promptly detect conduct similar to that which gave rise to this resolution. Among other things, the CIA requires Endo to implement an internal risk assessment and mitigation program and requires numerous internal and external reviews of promotional and other practices. The CIA also requires key executives and individual board members to sign certifications about compliance, and it requires the company to publicly report information about its financial arrangements with physicians.
“By marketing Lidoderm for uses not covered by federal health care programs, Endo profited at the expense of taxpayers and could have put patients at risk,” said Inspector General of the U.S. Department of Health and Human Services Daniel R. Levinson. “Under our CIA, Endo agrees to promote its products legally, while board members and top executives are specifically held accountable for compliance.”
The civil settlement resolves three lawsuits pending in federal court in the Eastern District of Pennsylvania under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the government and to share in any recovery. The actions were filed by Peggy Ryan, a former Lidoderm sales representative, Max Weathersby, another former Lidoderm sales representative and Gursheel S. Dhillon, a physician. The whistleblowers’ share of the settlement has not been determined.
This settlement illustrates the government’s emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by Attorney General Eric Holder and Secretary of Health and Human Services Kathleen Sebelius. The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation. One of the most powerful tools in this effort is the False Claims Act. Since January 2009, the Justice Department has recovered a total of more than $19 billion through False Claims Act cases, with more than $13.4 billion of that amount recovered in cases involving fraud against federal health care programs.
The civil settlement was handled by the U.S. Attorney’s Office for the Eastern District of Pennsylvania and the Civil Division’s Commercial Litigation Branch. The criminal case was handled by the U.S. Attorney’s Office for the Northern District of New York and the Civil Division’s Consumer Protection Branch. These matters were investigated by the Federal Bureau of Investigation, the Food and Drug Administration Office of Criminal Investigation, the Department of Health and Human Services Office of Inspector General Office of Investigations, the Defense Criminal Investigative Service of the Department of Defense, the U.S. Postal Service Office of Inspector General and the Office of Personnel Management Office of Inspector General with assistance from the Department of Health and Human Services Office of Counsel to the Inspector General and Office of General Counsel and Center for Medicare and Medicaid Services, the Food and Drug Administration’s Office of Chief Counsel and the National Association of Medicaid Fraud Control Units.
Except as to conduct admitted in connection with the deferred prosecution agreement, the claims settled by the civil agreement are allegations only, and there has been no determination of civil liability. The civil lawsuits are captioned United States ex rel. Ryan v. Endo Pharmaceuticals Inc., Civil Action No. 05-cv-3450, United States ex rel. Weathersby, et al. v. Endo Pharmaceuticals Inc., et al, Civil Action No. 10-cv-2039 and United States ex rel. Dhillon v. Endo Pharmaceuticals, Civil Action No. 11-cv-7767, all docketed in the Eastern District of Pennsylvania.
Friday, February 21, 2014
Endo Pharmaceuticals and Endo Health Solutions to Pay $192.7 Million to Resolve Criminal and Civil Liability Relating to Marketing of Prescription Drug Lidoderm for Unapproved Uses
Pharmaceutical company Endo Health Solutions Inc. and its subsidiary Endo Pharmaceuticals Inc. (Endo) have agreed to pay $192.7 million to resolve criminal and civil liability arising from Endo’s marketing of the prescription drug Lidoderm for uses not approved as safe and effective by the Food and Drug Administration (FDA), the Justice Department announced today. The resolution includes a deferred prosecution agreement and forfeiture totaling $20.8 million and civil false claims settlements with the federal government and the states and the District of Columbia totaling $171.9 million. Endo Pharmaceuticals Inc. is a Delaware corporation headquartered in Malvern, Pa.
“FDA’s drug approval process is designed to ensure that companies market their products for uses that are proven to be safe and effective,” said Assistant Attorney General for the Justice Department’s Civil Division Stuart F. Delery. “We will hold accountable those who circumvent that process in pursuit of financial gain.”
In a criminal information filed today in the Northern District of New York, the government charged that, between 2002 and 2006, Endo Pharmaceuticals Inc. introduced into interstate commerce Lidoderm that was misbranded under the Federal Food, Drug and Cosmetic Act (FDCA). The FDCA requires a company, such as Endo Pharmaceuticals Inc., to specify the intended uses of a product in its new drug application to the FDA. Once approved, a drug may not be introduced into interstate commerce for unapproved or “off-label” uses until the company receives FDA approval for the new intended uses. During the period of 2002 to 2006, Lidoderm was approved by the FDA only for the relief of pain associated with post-herpetic neuralgia (PHN), a complication of shingles. The information alleges that, during the relevant time period, the Lidoderm distributed nationwide by Endo Pharmaceuticals Inc. was misbranded because its labeling lacked adequate directions for use in the treatment of non-PHN related pain, including low back pain, diabetic neuropathy and carpal tunnel syndrome. These uses were intended by Endo Pharmaceuticals Inc. but never approved by the FDA. The information further alleges that certain Endo Pharmaceuticals Inc. sales managers provided instruction to certain sales representatives concerning how to expand sales conversations with doctors beyond PHN and encouraged promotion of Lidoderm in workers’ compensation clinics.
In a deferred prosecution agreement to resolve the charge, Endo Pharmaceuticals Inc. admitted that it intended that Lidoderm be used for unapproved indications and that it promoted Lidoderm to health care providers for those unapproved indications. Under the terms of the deferred prosecution agreement, Endo Pharmaceuticals Inc. will pay a total of $20.8 million in monetary penalties and forfeiture. Endo Pharmaceuticals Inc. further agreed to implement and maintain a number of enhanced compliance measures, including making publicly available the results of certain clinical trials and requiring an annual review and certification of its compliance efforts by the Chief Executive Officer of its parent company, Endo Health Solutions. The deferred prosecution agreement will not be final until accepted by the U.S. District Court for the Northern District of New York.
“The safety and efficacy of drugs must be shown by science, not sales pitches,” said U.S. Attorney for the Northern District of New York Richard S. Hartunian. “Drugs marketed for intended uses not approved by the FDA are misbranded because their labeling lacks adequate directions for those uses. This settlement emphasizes that public health is protected by labeling based on product performance, rather than profitability, and promotes enhanced efforts to ensure compliance with all requirements.”
In addition, Endo agreed to settle its potential civil liability in connection with its marketing of Lidoderm. The government alleged that, from March 1999 through December 2007, Endo caused false claims to be submitted to federal health care programs, including Medicaid, a jointly funded federal and state program, by promoting Lidoderm for unapproved uses, some of which were not medically accepted indications and, therefore, were not covered by the federal health care programs. Of the $171.9 million Endo has agreed to pay to resolve these civil claims, Endo will pay $137.7 million to the federal government and $34.2 million to the states and the District of Columbia.
“Off-label marketing can undermine the doctor-patient relationship and adversely influence the clear and honest judgment of doctors that their patients rely on and trust,” said U.S. Attorney for the Eastern District of Pennsylvania Zane D. Memeger. “Pharmaceutical companies have a legal obligation to promote their drugs for only FDA-approved uses. This obligation takes precedence over the company’s bottom line.”
“The settlement announced today demonstrates the government’s continued scrutiny of pharmaceutical companies that interfere with FDA’s mission of ensuring that drugs are safe and effective for the American public,” said Special Agent in Charge of the FDA’s Office of Criminal Investigations’ New York Field Office Mark Dragonetti. “We will continue to work with our law enforcement partners to investigate and prosecute pharmaceutical companies that disregard the drug approval process and jeopardize the public health by engaging in the nationwide distribution of misbranded products.”
“Endo Pharmaceutical enriched themselves at the expense of the public,” said Special Agent in Charge Andrew W. Vale of the Albany Division of the Federal Bureau of Investigation. “Patients will search for drug therapies to assist in pain management, and they deserve the right to drugs approved for such use. The FBI will continue to work with our federal partners to investigate companies such as Endo Pharmaceuticals to ensure patients are safe.”
Also as part of the settlement, Endo Pharmaceuticals Inc. has agreed to enter into a Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General that requires Endo to implement measures designed to avoid or promptly detect conduct similar to that which gave rise to this resolution. Among other things, the CIA requires Endo to implement an internal risk assessment and mitigation program and requires numerous internal and external reviews of promotional and other practices. The CIA also requires key executives and individual board members to sign certifications about compliance, and it requires the company to publicly report information about its financial arrangements with physicians.
“By marketing Lidoderm for uses not covered by federal health care programs, Endo profited at the expense of taxpayers and could have put patients at risk,” said Inspector General of the U.S. Department of Health and Human Services Daniel R. Levinson. “Under our CIA, Endo agrees to promote its products legally, while board members and top executives are specifically held accountable for compliance.”
The civil settlement resolves three lawsuits pending in federal court in the Eastern District of Pennsylvania under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the government and to share in any recovery. The actions were filed by Peggy Ryan, a former Lidoderm sales representative, Max Weathersby, another former Lidoderm sales representative and Gursheel S. Dhillon, a physician. The whistleblowers’ share of the settlement has not been determined.
This settlement illustrates the government’s emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by Attorney General Eric Holder and Secretary of Health and Human Services Kathleen Sebelius. The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation. One of the most powerful tools in this effort is the False Claims Act. Since January 2009, the Justice Department has recovered a total of more than $19 billion through False Claims Act cases, with more than $13.4 billion of that amount recovered in cases involving fraud against federal health care programs.
The civil settlement was handled by the U.S. Attorney’s Office for the Eastern District of Pennsylvania and the Civil Division’s Commercial Litigation Branch. The criminal case was handled by the U.S. Attorney’s Office for the Northern District of New York and the Civil Division’s Consumer Protection Branch. These matters were investigated by the Federal Bureau of Investigation, the Food and Drug Administration Office of Criminal Investigation, the Department of Health and Human Services Office of Inspector General Office of Investigations, the Defense Criminal Investigative Service of the Department of Defense, the U.S. Postal Service Office of Inspector General and the Office of Personnel Management Office of Inspector General with assistance from the Department of Health and Human Services Office of Counsel to the Inspector General and Office of General Counsel and Center for Medicare and Medicaid Services, the Food and Drug Administration’s Office of Chief Counsel and the National Association of Medicaid Fraud Control Units.
Except as to conduct admitted in connection with the deferred prosecution agreement, the claims settled by the civil agreement are allegations only, and there has been no determination of civil liability. The civil lawsuits are captioned United States ex rel. Ryan v. Endo Pharmaceuticals Inc., Civil Action No. 05-cv-3450, United States ex rel. Weathersby, et al. v. Endo Pharmaceuticals Inc., et al, Civil Action No. 10-cv-2039 and United States ex rel. Dhillon v. Endo Pharmaceuticals, Civil Action No. 11-cv-7767, all docketed in the Eastern District of Pennsylvania.
Wednesday, February 12, 2014
FDA APPROVES EXPANDED USE OF IMBRUVICA TO TREAT CHRONIC LYMPHOCYTIC LEUKEMIA
FROM: FOOD AND DRUG ADMINISTRATION
FDA NEWS RELEASE
For Immediate Release: Feb. 12, 2014
FDA approves Imbruvica to treat chronic lymphocytic leukemia
The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) for chronic lymphocytic leukemia (CLL) patients who have received at least one previous therapy.
CLL is a rare blood and bone marrow disease that usually gets worse slowly over time, causing a gradual increase in white blood cells called B lymphocytes, or B cells. The National Cancer Institute estimates that 15,680 Americans were diagnosed and 4,580 died from the disease in 2013.
Imbruvica works by blocking the enzyme that allows cancer cells to grow and divide. In November 2013, the FDA granted Imbruvica accelerated approval to treat patients with mantle cell lymphoma, a rare and aggressive type of blood cancer, if those patients received at least one prior therapy.
“Today’s approval provides an important new treatment option for CLL patients whose cancer has progressed despite having undergone previous therapy,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “The FDA completed its review of Imbruvica’s new indication under the agency’s accelerated approval process, which played a vital role in rapidly making this new therapy available to those who need it most.”
Under the agency’s accelerated approval process, the FDA may approve a drug based on a surrogate or intermediate endpoint that is reasonably likely to predict clinical benefit. Drugs receiving accelerated approval are usually subject to an agreement to conduct confirmatory trials verifying and describing clinical benefit. Imbruvica for CLL also received priority review and orphan-product designation because the drug demonstrated the potential to be a significant improvement in safety or effectiveness in the treatment of a serious condition and is intended to treat a rare disease, respectively.
The FDA’s accelerated approval of Imbruvica for CLL is based on a clinical study of 48 previously treated participants. On average, participants were diagnosed with CLL 6.7 years prior to the study and had received four previous therapies. All study participants received a 420 milligram orally administered dose of Imbruvica until the treatment reached unacceptable toxicity or the disease progressed. Results showed nearly 58 percent of participants had their cancer shrink after treatment (overall response rate). At the time of the study, the duration of response ranged from 5.6 to 24.2 months. An improvement in survival or disease-related symptoms has not been established.
The most common side effects observed in the clinical study include low levels of platelets in the blood (thrombocytopenia), diarrhea, bruising, a decrease in infection-fighting white blood cells (neutropenia), low red blood cells (anemia), upper respiratory tract infection, fatigue, pain in the muscles and bones (musculoskeletal pain), rash, fever (pyrexia), constipation, swelling of tissues (peripheral edema), joint pain (arthralgia), nausea, mouth sores (stomatitis), sinus infection (sinusitis) and dizziness.
Imbruvica is manufactured by Sunnyvale, Calif.-based Pharmacyclics.
FDA NEWS RELEASE
For Immediate Release: Feb. 12, 2014
FDA approves Imbruvica to treat chronic lymphocytic leukemia
The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) for chronic lymphocytic leukemia (CLL) patients who have received at least one previous therapy.
CLL is a rare blood and bone marrow disease that usually gets worse slowly over time, causing a gradual increase in white blood cells called B lymphocytes, or B cells. The National Cancer Institute estimates that 15,680 Americans were diagnosed and 4,580 died from the disease in 2013.
Imbruvica works by blocking the enzyme that allows cancer cells to grow and divide. In November 2013, the FDA granted Imbruvica accelerated approval to treat patients with mantle cell lymphoma, a rare and aggressive type of blood cancer, if those patients received at least one prior therapy.
“Today’s approval provides an important new treatment option for CLL patients whose cancer has progressed despite having undergone previous therapy,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “The FDA completed its review of Imbruvica’s new indication under the agency’s accelerated approval process, which played a vital role in rapidly making this new therapy available to those who need it most.”
Under the agency’s accelerated approval process, the FDA may approve a drug based on a surrogate or intermediate endpoint that is reasonably likely to predict clinical benefit. Drugs receiving accelerated approval are usually subject to an agreement to conduct confirmatory trials verifying and describing clinical benefit. Imbruvica for CLL also received priority review and orphan-product designation because the drug demonstrated the potential to be a significant improvement in safety or effectiveness in the treatment of a serious condition and is intended to treat a rare disease, respectively.
The FDA’s accelerated approval of Imbruvica for CLL is based on a clinical study of 48 previously treated participants. On average, participants were diagnosed with CLL 6.7 years prior to the study and had received four previous therapies. All study participants received a 420 milligram orally administered dose of Imbruvica until the treatment reached unacceptable toxicity or the disease progressed. Results showed nearly 58 percent of participants had their cancer shrink after treatment (overall response rate). At the time of the study, the duration of response ranged from 5.6 to 24.2 months. An improvement in survival or disease-related symptoms has not been established.
The most common side effects observed in the clinical study include low levels of platelets in the blood (thrombocytopenia), diarrhea, bruising, a decrease in infection-fighting white blood cells (neutropenia), low red blood cells (anemia), upper respiratory tract infection, fatigue, pain in the muscles and bones (musculoskeletal pain), rash, fever (pyrexia), constipation, swelling of tissues (peripheral edema), joint pain (arthralgia), nausea, mouth sores (stomatitis), sinus infection (sinusitis) and dizziness.
Imbruvica is manufactured by Sunnyvale, Calif.-based Pharmacyclics.
Saturday, February 8, 2014
STANDARDS SET FOR INFANT FORMULA
FROM: FOOD AND DRUG ADMINISTRATION
FDA Sets Standards for Infant Formula
February 6, 2014
The Food and Drug Administration today released an interim final rule that sets standards for manufacturers to produce safe infant formula that supports healthy growth.
While breastfeeding is strongly recommended and many mothers hope to breastfeed, most U.S. infants rely on infant formula for some portion of their nutrition. The interim final rule applies only to infant formulas represented for use by healthy infants without unusual medical or dietary problems.
The interim final rule amends FDA's quality control procedures, requirements about how and when manufacturers must notify the agency about new formulas and changes to formulas, and requirements concerning what manufacturing and related records and reports must be established and maintained. It establishes current good manufacturing practices specifically designed for infant formula, including required testing for contamination from harmful bacteria such as Salmonella. In addition, the interim final rule will help ensure that infant formula contains all federally required nutrients, such as protein, fat, and certain vitamins and minerals, and that the formula supports healthy growth.
Companies currently manufacturing infant formula in the U.S. have been producing safe infant formula in compliance with requirements of the Infant Formula Act, and these firms voluntarily conduct many of the current good manufacturing practices and quality control procedures included in the interim final rule. Following publication of the rule, FDA will accept and review comments on issues or information not previously considered.
FDA is also publishing two draft guidance documents to provide industry with additional information related to the interim final rule. One draft guidance document addresses the manufacture of infant formula products made for infants with unusual medical or dietary problems, such as infants who are born extremely premature and have special dietary needs; this type of formula is not the subject of the interim final rule. The other draft guidance document explains how manufacturers of currently and previously marketed infant formulas can demonstrate that their products meet the quality factor requirements of the interim final rule.
FDA Sets Standards for Infant Formula
February 6, 2014
The Food and Drug Administration today released an interim final rule that sets standards for manufacturers to produce safe infant formula that supports healthy growth.
While breastfeeding is strongly recommended and many mothers hope to breastfeed, most U.S. infants rely on infant formula for some portion of their nutrition. The interim final rule applies only to infant formulas represented for use by healthy infants without unusual medical or dietary problems.
The interim final rule amends FDA's quality control procedures, requirements about how and when manufacturers must notify the agency about new formulas and changes to formulas, and requirements concerning what manufacturing and related records and reports must be established and maintained. It establishes current good manufacturing practices specifically designed for infant formula, including required testing for contamination from harmful bacteria such as Salmonella. In addition, the interim final rule will help ensure that infant formula contains all federally required nutrients, such as protein, fat, and certain vitamins and minerals, and that the formula supports healthy growth.
Companies currently manufacturing infant formula in the U.S. have been producing safe infant formula in compliance with requirements of the Infant Formula Act, and these firms voluntarily conduct many of the current good manufacturing practices and quality control procedures included in the interim final rule. Following publication of the rule, FDA will accept and review comments on issues or information not previously considered.
FDA is also publishing two draft guidance documents to provide industry with additional information related to the interim final rule. One draft guidance document addresses the manufacture of infant formula products made for infants with unusual medical or dietary problems, such as infants who are born extremely premature and have special dietary needs; this type of formula is not the subject of the interim final rule. The other draft guidance document explains how manufacturers of currently and previously marketed infant formulas can demonstrate that their products meet the quality factor requirements of the interim final rule.
Friday, January 24, 2014
FDA STATEMENT: IOM REPORT ON CAFFEINE IN FOOD AND DIETARY SUPPLEMENTS
FROM: FOOD AND DRUG ADMINISTRATION
FDA STATEMENT
Jan. 17, 2014
Consumer Inquiries: 888-INFO-FDA
FDA Deputy Commissioner for Foods and Veterinary Medicine Michael R. Taylor's Statement on the Institute of Medicine Report on Caffeine in Food and Dietary Supplements
The FDA thanks the Institute of Medicine (IOM) for convening the Aug. 5-6, 2013, public workshop on caffeine in food and dietary supplements. The FDA requested the workshop because we know how important it is to get the science right. The summary report that IOM issued today will be extremely informative as we continue our investigation of the safety of caffeine, particularly its effects on children and adolescents.
In the last ten years, the marketplace has seen an influx of caffeinated energy drinks and a wide range of foods with added caffeine. It is apparent that caffeine is now appearing in a range of new foods and beverages. We are especially concerned with products that may be attractive and readily available to children and adolescents, without careful consideration of their cumulative impact.
Since the IOM workshop, we have engaged in a dialog with industry, consumers and the scientific community on a number of options to address this important public health issue. We appreciate the voluntary restraint that some companies have shown as we continue to investigate safe levels of caffeine consumption.
With public safety as our top priority, we also continue to investigate each adverse event report we receive on energy drinks and other caffeinated products. We have just recently moved to an online adverse event reporting system for dietary supplements that will make it easier for the FDA to detect dietary supplements that pose risk for a range of reasons, including excessive levels of caffeine.
FDA STATEMENT
Jan. 17, 2014
Consumer Inquiries: 888-INFO-FDA
FDA Deputy Commissioner for Foods and Veterinary Medicine Michael R. Taylor's Statement on the Institute of Medicine Report on Caffeine in Food and Dietary Supplements
The FDA thanks the Institute of Medicine (IOM) for convening the Aug. 5-6, 2013, public workshop on caffeine in food and dietary supplements. The FDA requested the workshop because we know how important it is to get the science right. The summary report that IOM issued today will be extremely informative as we continue our investigation of the safety of caffeine, particularly its effects on children and adolescents.
In the last ten years, the marketplace has seen an influx of caffeinated energy drinks and a wide range of foods with added caffeine. It is apparent that caffeine is now appearing in a range of new foods and beverages. We are especially concerned with products that may be attractive and readily available to children and adolescents, without careful consideration of their cumulative impact.
Since the IOM workshop, we have engaged in a dialog with industry, consumers and the scientific community on a number of options to address this important public health issue. We appreciate the voluntary restraint that some companies have shown as we continue to investigate safe levels of caffeine consumption.
With public safety as our top priority, we also continue to investigate each adverse event report we receive on energy drinks and other caffeinated products. We have just recently moved to an online adverse event reporting system for dietary supplements that will make it easier for the FDA to detect dietary supplements that pose risk for a range of reasons, including excessive levels of caffeine.
Monday, January 20, 2014
HOW FDA REGULATES HUMAN TISSUE AND TISSUE PRODUCTS
FROM: FOOD AND DRUG ADMINISTRATION
Tissue & Tissue Products
Human cells or tissue intended for implantation, transplantation, infusion, or transfer into a human recipient is regulated as a human cell, tissue, and cellular and tissue-based product or HCT/P. The Center for Biologics Evaluation and Research (CBER) regulates HCT/Ps under 21 CFR Parts 1270 and 1271.
Examples of such tissues are bone, skin, corneas, ligaments, tendons, dura mater, heart valves, hematopoietic stem/progenitor cells derived from peripheral and cord blood, oocytes and semen. CBER does not regulate the transplantation of vascularized human organ transplants such as kidney, liver, heart, lung or pancreas. The Health Resources Services Administration (HRSA) oversees the transplantation of vascularized human organs.
Parts 1270 and 1271 require tissue establishments to screen and test donors, to prepare and follow written procedures for the prevention of the spread of communicable disease, and to maintain records. FDA has published three final rules to broaden the scope of products subject to regulation and to include more comprehensive requirements to prevent the introduction, transmission and spread of communicable disease. One final rule requires firms to register and list their HCT/Ps with FDA. The second rule requires tissue establishments to evaluate donors, through screening and testing, to reduce the transmission of infectious diseases through tissue transplantation. The third final rule establishes current good tissue practices for HCT/Ps. FDA's revised regulations are contained in Part 1271 and apply to tissues recovered after May 25, 2005. The new requirements are intended to improve protection of the public health while minimizing regulatory burden.
Tissue & Tissue Products
Human cells or tissue intended for implantation, transplantation, infusion, or transfer into a human recipient is regulated as a human cell, tissue, and cellular and tissue-based product or HCT/P. The Center for Biologics Evaluation and Research (CBER) regulates HCT/Ps under 21 CFR Parts 1270 and 1271.
Examples of such tissues are bone, skin, corneas, ligaments, tendons, dura mater, heart valves, hematopoietic stem/progenitor cells derived from peripheral and cord blood, oocytes and semen. CBER does not regulate the transplantation of vascularized human organ transplants such as kidney, liver, heart, lung or pancreas. The Health Resources Services Administration (HRSA) oversees the transplantation of vascularized human organs.
Parts 1270 and 1271 require tissue establishments to screen and test donors, to prepare and follow written procedures for the prevention of the spread of communicable disease, and to maintain records. FDA has published three final rules to broaden the scope of products subject to regulation and to include more comprehensive requirements to prevent the introduction, transmission and spread of communicable disease. One final rule requires firms to register and list their HCT/Ps with FDA. The second rule requires tissue establishments to evaluate donors, through screening and testing, to reduce the transmission of infectious diseases through tissue transplantation. The third final rule establishes current good tissue practices for HCT/Ps. FDA's revised regulations are contained in Part 1271 and apply to tissues recovered after May 25, 2005. The new requirements are intended to improve protection of the public health while minimizing regulatory burden.
Friday, January 17, 2014
FDA WARNS OF WART REMOVER FIRES
FROM: FOOD AND DRUG ADMINISTRATION
Some cryogenic wart removers—which remove warts from the skin by freezing them off—have caught fire during use at home, harming consumers or setting fire to items around the house.
Since 2009, the Food and Drug Administration (FDA)—which regulates wart removers as medical devices—has received 14 such reports about over-the-counter (OTC) wart remover products, which are a mixture of liquid dimethyl ether and propane.
Ten patients have described singed hair, blisters, burns or skin redness, according to FDA nurse consultant Karen Nast, RN. Nearby items have also caught fire.
"The labeling for these products clearly states that they are flammable and should be kept away from fire, flame, heat sources, and cigarettes," Nast notes. In three of the reports, there was a candle nearby, but in the other 11 reports no ignition source was identified. "This is extremely concerning, especially because people may not be aware that everyday household items like curling irons and straight irons can be hot enough to be an ignition source for these products," Nast says.
How to Use These Products
Warts are growths caused by human papillomavirus (HPV) infection. Most treatments using a mixture of liquid dimethyl ether and propane instruct users to follow certain steps.
First, the user presses on the nozzle of a small, pressurized canister (dispenser) containing the mixture. The dispenser releases the mixture, cooled to approximately -40 degrees Celsius, onto an applicator, saturating it. (In some products, the applicator is attached to the cap.) The user presses the applicator on the wart for the amount of time specified in the product directions. An average of three to four treatments is required for warts on thin skin. Warts on calloused skin, such as plantar warts on the soles of the feet, might take more treatments.
In the reports FDA has received, the dispenser generally caught fire when it was releasing the mixture.
Some cryogenic wart removers—which remove warts from the skin by freezing them off—have caught fire during use at home, harming consumers or setting fire to items around the house.
Since 2009, the Food and Drug Administration (FDA)—which regulates wart removers as medical devices—has received 14 such reports about over-the-counter (OTC) wart remover products, which are a mixture of liquid dimethyl ether and propane.
Ten patients have described singed hair, blisters, burns or skin redness, according to FDA nurse consultant Karen Nast, RN. Nearby items have also caught fire.
"The labeling for these products clearly states that they are flammable and should be kept away from fire, flame, heat sources, and cigarettes," Nast notes. In three of the reports, there was a candle nearby, but in the other 11 reports no ignition source was identified. "This is extremely concerning, especially because people may not be aware that everyday household items like curling irons and straight irons can be hot enough to be an ignition source for these products," Nast says.
How to Use These Products
Warts are growths caused by human papillomavirus (HPV) infection. Most treatments using a mixture of liquid dimethyl ether and propane instruct users to follow certain steps.
First, the user presses on the nozzle of a small, pressurized canister (dispenser) containing the mixture. The dispenser releases the mixture, cooled to approximately -40 degrees Celsius, onto an applicator, saturating it. (In some products, the applicator is attached to the cap.) The user presses the applicator on the wart for the amount of time specified in the product directions. An average of three to four treatments is required for warts on thin skin. Warts on calloused skin, such as plantar warts on the soles of the feet, might take more treatments.
In the reports FDA has received, the dispenser generally caught fire when it was releasing the mixture.
Thursday, January 16, 2014
FDA RECOMMENDED MAXIMUM AMOUNT OF ACETAMINOPHEN PER TABLET
FROM: FOOD AND DRUG ADMINISTRATION
The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
On January 14, 2014, FDA is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule, or other dosage unit. There are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury. Further, limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant, and death.
We recommend that health care providers consider prescribing combination drug products that contain 325 mg or less of acetaminophen. We also recommend that when a pharmacist receives a prescription for a combination product with more than 325 mg of acetaminophen per dosage unit that they contact the prescriber to discuss a product with a lower dose of acetaminophen. A two tablet or two capsule dose may still be prescribed, if appropriate. In that case, the total dose of acetaminophen would be 650 mg (the amount in two 325 mg dosage units). When making individual dosing determinations, health care providers should always consider the amounts of both the acetaminophen and the opioid components in the prescription combination drug product.
In January 2011 we asked manufacturers of prescription combination drug products containing acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule by January 14, 2014. We requested this action to protect consumers from the risk of severe liver damage which can result from taking too much acetaminophen. This category of prescription drugs combines acetaminophen with another ingredient intended to treat pain (most often an opioid), and these products are commonly prescribed to consumers for pain, such as pain from acute injuries, post-operative pain, or pain following dental procedures.
The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
On January 14, 2014, FDA is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule, or other dosage unit. There are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury. Further, limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant, and death.
We recommend that health care providers consider prescribing combination drug products that contain 325 mg or less of acetaminophen. We also recommend that when a pharmacist receives a prescription for a combination product with more than 325 mg of acetaminophen per dosage unit that they contact the prescriber to discuss a product with a lower dose of acetaminophen. A two tablet or two capsule dose may still be prescribed, if appropriate. In that case, the total dose of acetaminophen would be 650 mg (the amount in two 325 mg dosage units). When making individual dosing determinations, health care providers should always consider the amounts of both the acetaminophen and the opioid components in the prescription combination drug product.
In January 2011 we asked manufacturers of prescription combination drug products containing acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule by January 14, 2014. We requested this action to protect consumers from the risk of severe liver damage which can result from taking too much acetaminophen. This category of prescription drugs combines acetaminophen with another ingredient intended to treat pain (most often an opioid), and these products are commonly prescribed to consumers for pain, such as pain from acute injuries, post-operative pain, or pain following dental procedures.
Friday, January 10, 2014
FDA APPROVES FARXIGA TABLETS FOR TREATMENT OF TYPE 2 DIABETES
FROM: FOOD AND DRUG ADMINISTRATION
FDA NEWS RELEASE
For Immediate Release: Jan. 8, 2014
FDA approves Farxiga to treat type 2 diabetes
The U.S. Food and Drug Administration today approved Farxiga (dapaglifozin) tablets to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.
Type 2 diabetes affects about 24 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.
“Controlling blood sugar levels is very important in the overall treatment and care of diabetes, and Farxiga provides an additional treatment option for millions of Americans with type 2 diabetes,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.
Farxiga is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that blocks the reabsorption of glucose by the kidney, increases glucose excretion, and lowers blood glucose levels. The drug’s safety and effectiveness were evaluated in 16 clinical trials involving more than 9,400 patients with type 2 diabetes. The trials showed improvement in HbA1c (hemoglogin A1c or glycosylated hemoglobin, a measure of blood sugar control).
Farxiga has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies including metformin, pioglitazone, glimepiride, sitagliptin, and insulin. Farxiga should not be used to treat people with type 1 diabetes; those who have increased ketones in their blood or urine (diabetic ketoacidosis); or those with moderate or severe renal impairment, end stage renal disease, or patients on dialysis.
An increased number of bladder cancers were diagnosed among Farxiga users in clinical trials so Farxiga is not recommended for patients with active bladder cancer. Patients with a history of bladder cancer should talk to their physician before using Farxiga. Farxiga can cause dehydration, leading to a drop in blood pressure (hypotension) that can result in dizziness and/or fainting and a decline in renal function. The elderly, patients with impaired renal function, and patients on diuretics to treat other conditions appeared to be more susceptible to this risk.
The FDA is requiring six post-marketing studies for Farxiga:
a cardiovascular outcomes trial (CVOT) to evaluate the cardiovascular risk of Farxiga in patients with high baseline risk of cardiovascular disease;
a double-blind, randomized, controlled assessment of bladder cancer risk in patients enrolled in the CVOT;
an animal study evaluating the role of Farxiga-induced urinary flow/rate and composition changes on bladder tumor promotion in rodents;
two clinical trials to assess the pharmacokinetics, efficacy, and safety in pediatric patients; and
an enhanced pharmacovigilance program to monitor reports of liver abnormalities and pregnancy outcomes.
In clinical trials the most common side effects observed in patients treated with Farxiga were genital mycotic (fungal) infections and urinary tract infections.
Farxiga is marketed by Bristol-Meyers Squibb Company, Princeton, N.J. and AstraZeneca Pharmaceuticals L.P., Wilmington, Del.
For more information:
FDA Approved Drugs
FDA: Drug Innovation
FDA: Diabetes Information
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
FDA NEWS RELEASE
For Immediate Release: Jan. 8, 2014
FDA approves Farxiga to treat type 2 diabetes
The U.S. Food and Drug Administration today approved Farxiga (dapaglifozin) tablets to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.
Type 2 diabetes affects about 24 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.
“Controlling blood sugar levels is very important in the overall treatment and care of diabetes, and Farxiga provides an additional treatment option for millions of Americans with type 2 diabetes,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.
Farxiga is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that blocks the reabsorption of glucose by the kidney, increases glucose excretion, and lowers blood glucose levels. The drug’s safety and effectiveness were evaluated in 16 clinical trials involving more than 9,400 patients with type 2 diabetes. The trials showed improvement in HbA1c (hemoglogin A1c or glycosylated hemoglobin, a measure of blood sugar control).
Farxiga has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies including metformin, pioglitazone, glimepiride, sitagliptin, and insulin. Farxiga should not be used to treat people with type 1 diabetes; those who have increased ketones in their blood or urine (diabetic ketoacidosis); or those with moderate or severe renal impairment, end stage renal disease, or patients on dialysis.
An increased number of bladder cancers were diagnosed among Farxiga users in clinical trials so Farxiga is not recommended for patients with active bladder cancer. Patients with a history of bladder cancer should talk to their physician before using Farxiga. Farxiga can cause dehydration, leading to a drop in blood pressure (hypotension) that can result in dizziness and/or fainting and a decline in renal function. The elderly, patients with impaired renal function, and patients on diuretics to treat other conditions appeared to be more susceptible to this risk.
The FDA is requiring six post-marketing studies for Farxiga:
a cardiovascular outcomes trial (CVOT) to evaluate the cardiovascular risk of Farxiga in patients with high baseline risk of cardiovascular disease;
a double-blind, randomized, controlled assessment of bladder cancer risk in patients enrolled in the CVOT;
an animal study evaluating the role of Farxiga-induced urinary flow/rate and composition changes on bladder tumor promotion in rodents;
two clinical trials to assess the pharmacokinetics, efficacy, and safety in pediatric patients; and
an enhanced pharmacovigilance program to monitor reports of liver abnormalities and pregnancy outcomes.
In clinical trials the most common side effects observed in patients treated with Farxiga were genital mycotic (fungal) infections and urinary tract infections.
Farxiga is marketed by Bristol-Meyers Squibb Company, Princeton, N.J. and AstraZeneca Pharmaceuticals L.P., Wilmington, Del.
For more information:
FDA Approved Drugs
FDA: Drug Innovation
FDA: Diabetes Information
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Thursday, January 9, 2014
FDA WARNS CONSUMERS OF POTENTIAL DANGERS OF OVER-THE-COUNTER LAXITIVES
FROM: FOOD AND DRUG ADMINISTRATION
Constipation may not be a subject for polite conversation, but it's a condition that bothers many of us on occasion.
The Food and Drug Administration (FDA) is warning consumers that some of the over-the-counter (OTC) laxatives they may turn to for relief are potentially dangerous if dosing instructions or warnings on the Drug Facts label are not properly followed or when there are certain coexisting health conditions. In fact, there have been dozens of reports of serious side effects, including 13 deaths, associated with the use of sodium phosphate laxatives.
The label of sodium phosphate laxatives states that they should be used as a single dose taken once a day, and the products should not be used for more than three days. Equally important, consumers who do not have a bowel movement after taking an oral or rectal dose should not take another dose of the product.
In addition, labeling instructs adults and children to ask health care professionals before using these products if they have kidney disease, heart problems or dehydration.
FDA is now warning that adults older than 55 and adults and children with certain health conditions should ask a health care professional before using these products because they may be at increased risk for harmful side effects. These new warnings are not currently in the Drug Facts label and apply to both adults and children.
who are taking certain drugs that affect how the kidneys work, such as diuretics or fluid medicines; angiotensin-converting enzyme (ACE) inhibitors used to lower blood pressure; angiotensin receptor blockers (ARBs) used to treat high blood pressure, heart, or kidney failure; and nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen.
with inflammation of the colon.
Constipation is marked by infrequent bowel movements or difficulty in passing stools.
Laxatives—taken both orally and rectally—come in different forms, with different ingredients. The sodium phosphate used in some products is in a class of medications called saline laxatives. This class of laxatives helps promote a bowel movement by drawing water into the bowel, which softens the stool and makes it easier to pass.
Laxative products containing sodium phosphates are marketed under the brand name "Fleet" and also as store brands and generic products. All of them are potentially associated with serious side effects, such as dehydration and/or abnormal levels of electrolytes in the blood that can lead to serious complications, such as kidney damage and sometimes death.
Who is Most at Risk?
According to Mona Khurana, M.D., a medical officer in FDA's Division of Nonprescription Regulation Development and a pediatric nephrologist (a doctor who specializes in children's kidney diseases), the most serious harm in recent reports occurred after consumers overdosed by taking a single dose that was higher than recommended on the drug label or took more than one dose in a day because they had a poor laxative effect from the first dose.
"The bottom line is that these products are safe for otherwise healthy adults and older children for whom dosing instructions are provided on the Drug Facts label as long as they follow these dosing instructions and don't take the product more often, or in greater amounts, than the label instructs," Khurana says.
In recent reviews of harmful side effects reported by consumers and health care professionals, FDA has identified 54 cases of serious side effects associated with the oral or rectal use of OTC sodium phosphate products for the treatment of constipation in adults and children. Thirteen cases were fatal, including one child and 12 adults.
"It is not possible to determine the precise rate of these events as no one knows how many individuals who take these medications may experience side effects," says Khurana, adding, "Not everybody who develops problems in association with sodium phosphate use reports to the FDA."
Can these laxatives be used safely in young children?
"Caregivers should not give these products orally to children under age 5 years without first asking a health care professional. Both caregivers and health care professionals should avoid the rectal use of these drug products in children under age 2 years," Khurana cautions. "These warnings against use in young children are listed on product labeling."
Warning Signs
Consumers taking these laxatives should watch for warning signs of a bad reaction. For example, a rectal dose that is retained and does not produce a bowel movement may cause dehydration and/or serious changes in blood electrolyte levels. Symptoms of dehydration include dry mouth, thirst, reduced urine output, and lightheadedness, especially with changes in position. If the rectal dose is retained in the body longer than 30 minutes, a health care professional should be contacted right away.
The symptoms of kidney injury include drowsiness, sluggishness, a decreased amount of urine, or swelling of the ankles, feet and legs. If you experience any of these symptoms after using laxatives containing sodium phosphates, you should seek medical attention immediately.
If you have any concerns about using the products, particularly for use with young children, talk to your health care professional first, Khurana says.
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Jan. 8, 2014
Constipation may not be a subject for polite conversation, but it's a condition that bothers many of us on occasion.
The Food and Drug Administration (FDA) is warning consumers that some of the over-the-counter (OTC) laxatives they may turn to for relief are potentially dangerous if dosing instructions or warnings on the Drug Facts label are not properly followed or when there are certain coexisting health conditions. In fact, there have been dozens of reports of serious side effects, including 13 deaths, associated with the use of sodium phosphate laxatives.
The label of sodium phosphate laxatives states that they should be used as a single dose taken once a day, and the products should not be used for more than three days. Equally important, consumers who do not have a bowel movement after taking an oral or rectal dose should not take another dose of the product.
In addition, labeling instructs adults and children to ask health care professionals before using these products if they have kidney disease, heart problems or dehydration.
FDA is now warning that adults older than 55 and adults and children with certain health conditions should ask a health care professional before using these products because they may be at increased risk for harmful side effects. These new warnings are not currently in the Drug Facts label and apply to both adults and children.
who are taking certain drugs that affect how the kidneys work, such as diuretics or fluid medicines; angiotensin-converting enzyme (ACE) inhibitors used to lower blood pressure; angiotensin receptor blockers (ARBs) used to treat high blood pressure, heart, or kidney failure; and nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen.
with inflammation of the colon.
Constipation is marked by infrequent bowel movements or difficulty in passing stools.
Laxatives—taken both orally and rectally—come in different forms, with different ingredients. The sodium phosphate used in some products is in a class of medications called saline laxatives. This class of laxatives helps promote a bowel movement by drawing water into the bowel, which softens the stool and makes it easier to pass.
Laxative products containing sodium phosphates are marketed under the brand name "Fleet" and also as store brands and generic products. All of them are potentially associated with serious side effects, such as dehydration and/or abnormal levels of electrolytes in the blood that can lead to serious complications, such as kidney damage and sometimes death.
Who is Most at Risk?
According to Mona Khurana, M.D., a medical officer in FDA's Division of Nonprescription Regulation Development and a pediatric nephrologist (a doctor who specializes in children's kidney diseases), the most serious harm in recent reports occurred after consumers overdosed by taking a single dose that was higher than recommended on the drug label or took more than one dose in a day because they had a poor laxative effect from the first dose.
"The bottom line is that these products are safe for otherwise healthy adults and older children for whom dosing instructions are provided on the Drug Facts label as long as they follow these dosing instructions and don't take the product more often, or in greater amounts, than the label instructs," Khurana says.
In recent reviews of harmful side effects reported by consumers and health care professionals, FDA has identified 54 cases of serious side effects associated with the oral or rectal use of OTC sodium phosphate products for the treatment of constipation in adults and children. Thirteen cases were fatal, including one child and 12 adults.
"It is not possible to determine the precise rate of these events as no one knows how many individuals who take these medications may experience side effects," says Khurana, adding, "Not everybody who develops problems in association with sodium phosphate use reports to the FDA."
Can these laxatives be used safely in young children?
"Caregivers should not give these products orally to children under age 5 years without first asking a health care professional. Both caregivers and health care professionals should avoid the rectal use of these drug products in children under age 2 years," Khurana cautions. "These warnings against use in young children are listed on product labeling."
Warning Signs
Consumers taking these laxatives should watch for warning signs of a bad reaction. For example, a rectal dose that is retained and does not produce a bowel movement may cause dehydration and/or serious changes in blood electrolyte levels. Symptoms of dehydration include dry mouth, thirst, reduced urine output, and lightheadedness, especially with changes in position. If the rectal dose is retained in the body longer than 30 minutes, a health care professional should be contacted right away.
The symptoms of kidney injury include drowsiness, sluggishness, a decreased amount of urine, or swelling of the ankles, feet and legs. If you experience any of these symptoms after using laxatives containing sodium phosphates, you should seek medical attention immediately.
If you have any concerns about using the products, particularly for use with young children, talk to your health care professional first, Khurana says.
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Jan. 8, 2014
Friday, January 3, 2014
FDA SAYS DIETARY SUPPLEMENTS WON'T TREAT CONCUSSIONS
FROM: FOOD AND DRUG ADMINISTRATION
Can a Dietary Supplement Treat a Concussion? No.
Exploiting the public's rising concern about concussions, some companies are offering untested, unproven and possibly dangerous products that claim to prevent, treat or cure concussions and other traumatic brain injuries (TBIs).
The Food and Drug Administration (FDA) is monitoring the marketplace and taking enforcement actions where appropriate, issuing warning letters to firms—the usual first step for dealing with claims that products labeled as dietary supplements are intended for use in the cure, mitigation, treatment, or prevention of disease. The agency is also warning consumers to avoid purported dietary supplements marketed with claims to prevent, treat, or cure concussions and other TBIs because the claims are not backed with scientific evidence that the products are safe or effective for such purposes. These products are sold on the Internet and at various retail outlets, and marketed to consumers using social media, including Facebook and Twitter.
One common claim: Using a particular dietary supplement promotes faster healing times after a concussion or other TBI.
Even if a particular supplement contains no harmful ingredients, that claim alone can be dangerous, says Gary Coody, FDA's National Health Fraud Coordinator.
"We're very concerned that false assurances of faster recovery will convince athletes of all ages, coaches and even parents that someone suffering from a concussion is ready to resume activities before they are really ready," says Coody. "Also, watch for claims that these products can prevent or lessen the severity of concussions or TBIs."
A concussion is a brain injury caused by a blow to the head, or by a violent shaking of the head and upper body. Concussions and other TBIs are serious medical conditions that require proper diagnosis, treatment, and monitoring by a health care professional. The long-term impact of concussions on professional athletes and children who play contact sports has recently been the subject of highly publicized discussions.
A growing body of scientific evidence indicates that if concussion victims resume strenuous activities—such as football, soccer or hockey—too soon, they risk a greater chance of having a subsequent concussion. Moreover, repeat concussions can have a cumulative effect on the brain, with devastating consequences that can include brain swelling, permanent brain damage, long-term disability and death.
"As amazing as the marketing claims here are, the science doesn't support the use of any dietary supplements for the prevention of concussions or the reduction of post-concussion symptoms that would enable one to return to playing a sport faster," says Daniel Fabricant, Ph.D., director of FDA's Division of Dietary Supplement Programs.
back to top
The Claims
One of the first alarms raised about dietary supplements being promoted to treat TBI came from the U.S. Department of Defense.
"We first learned from the military about a product being marketed to treat TBI, obviously a concern with wounded veterans. We were taken aback that anyone would make a claim that a supplement could treat TBI, a hot-button issue," says Jason Humbert, a senior regulatory manager with FDA's Office of Regulatory Affairs. "That sparked our surveillance."
FDA routinely monitors the marketplace. However, with more than 85,000 dietary supplements on the market and no product registration, products making false claims can slip through, at least for a time.
Typically, products promising relief from TBIs tout the benefits of ingredients such as turmeric and high levels of omega-3 fatty acids derived from fish oil. Turmeric is an Indian spice in the ginger family. For Omega-3, FDA has recommended a maximum daily level of 3 grams per day from all sources due to possible problems with increased risk of bleeding, increases in cholesterol and problems with controlling blood sugar levels.
In its initial surveillance, FDA identified two companies selling multiple products claiming to prevent and treat concussions and other TBIs. One company claimed to have "the world's first supplement formulated specifically to assist concussion recovery," saying "it has the dynamic ability to minimize long-term effects and decrease recovery time." A National Football League player testified to its "proven results in my own recovery" from a concussion, and an unnamed "licensed trainer" said he had incorporated it into his "concussion management protocol."
Similar claims were made by the other company, which was selling four products claiming to protect against and help heal TBIs. FDA sent letters in 2012 warning both companies that their products were not generally recognized as safe and effective for treating TBIs, that the products were misbranded (a legal term meaning, in this case, that the labeling of the products did not have adequate directions for use), and that unless various violations cited in the letters were promptly corrected, the violations could result in legal action taken without further notice, such as seizure or injunction.
Both companies changed their websites and labeling.
In December 2013, FDA issued a warning letter to Star Scientific, Inc., for marketing its product Anatabloc with claims to treat TBIs. FDA continues to monitor the marketplace for products with similar fraudulent claims, and will take appropriate regulatory action to protect the public health.
"As we continue to work on this problem, we can't guarantee you won't see a claim about TBIs. But we can promise you this: There is no dietary supplement that has been shown to prevent or treat them," says Coody. "If someone tells you otherwise, walk away."
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Dec. 31, 2013
Can a Dietary Supplement Treat a Concussion? No.
Exploiting the public's rising concern about concussions, some companies are offering untested, unproven and possibly dangerous products that claim to prevent, treat or cure concussions and other traumatic brain injuries (TBIs).
The Food and Drug Administration (FDA) is monitoring the marketplace and taking enforcement actions where appropriate, issuing warning letters to firms—the usual first step for dealing with claims that products labeled as dietary supplements are intended for use in the cure, mitigation, treatment, or prevention of disease. The agency is also warning consumers to avoid purported dietary supplements marketed with claims to prevent, treat, or cure concussions and other TBIs because the claims are not backed with scientific evidence that the products are safe or effective for such purposes. These products are sold on the Internet and at various retail outlets, and marketed to consumers using social media, including Facebook and Twitter.
One common claim: Using a particular dietary supplement promotes faster healing times after a concussion or other TBI.
Even if a particular supplement contains no harmful ingredients, that claim alone can be dangerous, says Gary Coody, FDA's National Health Fraud Coordinator.
"We're very concerned that false assurances of faster recovery will convince athletes of all ages, coaches and even parents that someone suffering from a concussion is ready to resume activities before they are really ready," says Coody. "Also, watch for claims that these products can prevent or lessen the severity of concussions or TBIs."
A concussion is a brain injury caused by a blow to the head, or by a violent shaking of the head and upper body. Concussions and other TBIs are serious medical conditions that require proper diagnosis, treatment, and monitoring by a health care professional. The long-term impact of concussions on professional athletes and children who play contact sports has recently been the subject of highly publicized discussions.
A growing body of scientific evidence indicates that if concussion victims resume strenuous activities—such as football, soccer or hockey—too soon, they risk a greater chance of having a subsequent concussion. Moreover, repeat concussions can have a cumulative effect on the brain, with devastating consequences that can include brain swelling, permanent brain damage, long-term disability and death.
"As amazing as the marketing claims here are, the science doesn't support the use of any dietary supplements for the prevention of concussions or the reduction of post-concussion symptoms that would enable one to return to playing a sport faster," says Daniel Fabricant, Ph.D., director of FDA's Division of Dietary Supplement Programs.
back to top
The Claims
One of the first alarms raised about dietary supplements being promoted to treat TBI came from the U.S. Department of Defense.
"We first learned from the military about a product being marketed to treat TBI, obviously a concern with wounded veterans. We were taken aback that anyone would make a claim that a supplement could treat TBI, a hot-button issue," says Jason Humbert, a senior regulatory manager with FDA's Office of Regulatory Affairs. "That sparked our surveillance."
FDA routinely monitors the marketplace. However, with more than 85,000 dietary supplements on the market and no product registration, products making false claims can slip through, at least for a time.
Typically, products promising relief from TBIs tout the benefits of ingredients such as turmeric and high levels of omega-3 fatty acids derived from fish oil. Turmeric is an Indian spice in the ginger family. For Omega-3, FDA has recommended a maximum daily level of 3 grams per day from all sources due to possible problems with increased risk of bleeding, increases in cholesterol and problems with controlling blood sugar levels.
In its initial surveillance, FDA identified two companies selling multiple products claiming to prevent and treat concussions and other TBIs. One company claimed to have "the world's first supplement formulated specifically to assist concussion recovery," saying "it has the dynamic ability to minimize long-term effects and decrease recovery time." A National Football League player testified to its "proven results in my own recovery" from a concussion, and an unnamed "licensed trainer" said he had incorporated it into his "concussion management protocol."
Similar claims were made by the other company, which was selling four products claiming to protect against and help heal TBIs. FDA sent letters in 2012 warning both companies that their products were not generally recognized as safe and effective for treating TBIs, that the products were misbranded (a legal term meaning, in this case, that the labeling of the products did not have adequate directions for use), and that unless various violations cited in the letters were promptly corrected, the violations could result in legal action taken without further notice, such as seizure or injunction.
Both companies changed their websites and labeling.
In December 2013, FDA issued a warning letter to Star Scientific, Inc., for marketing its product Anatabloc with claims to treat TBIs. FDA continues to monitor the marketplace for products with similar fraudulent claims, and will take appropriate regulatory action to protect the public health.
"As we continue to work on this problem, we can't guarantee you won't see a claim about TBIs. But we can promise you this: There is no dietary supplement that has been shown to prevent or treat them," says Coody. "If someone tells you otherwise, walk away."
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Dec. 31, 2013
Tuesday, December 17, 2013
FDA QUESTIONS SAFETY, EFFECTIVENESS OF ANTIBACTERIAL SOAPS
FROM: U.S. FOOD AND DRUG ADMINISTRATION
FDA NEWS RELEASE
FDA issues proposed rule to determine safety and effectiveness of antibacterial soaps
The U.S. Food and Drug Administration today issued a proposed rule to require manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Under the proposal, if companies do not demonstrate such safety and effectiveness, these products would need to be reformulated or relabeled to remain on the market.
Today’s action is part of a larger, ongoing review of antibacterial active ingredients by the FDA to ensure these ingredients are proven to be safe and effective. This proposed rule does not affect hand sanitizers, wipes, or antibacterial products used in health care settings.
Millions of Americans use antibacterial hand soap and body wash products. Although consumers generally view these products as effective tools to help prevent the spread of germs, there is currently no evidence that they are any more effective at preventing illness than washing with plain soap and water. Further, some data suggest that long-term exposure to certain active ingredients used in antibacterial products—for example, triclosan (liquid soaps) and triclocarban (bar soaps)—could pose health risks, such as bacterial resistance or hormonal effects.
“Antibacterial soaps and body washes are used widely and frequently by consumers in everyday home, work, school, and public settings, where the risk of infection is relatively low,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “Due to consumers’ extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk.”
The widespread consumer use of antibacterial products, the accumulated scientific information and concerns raised by health care and consumer groups have prompted the FDA to reevaluate what data are needed to classify the active ingredients in consumer antibacterial products as “generally recognized as safe and effective” or GRASE. Under the proposed rule, manufacturers who want to continue marketing antibacterial products will be required to provide the agency with additional data on the products’ safety and effectiveness, including data from clinical studies to demonstrate that these products are superior to non-antibacterial soaps in preventing human illness or reducing infection.
“While the FDA continues to collect additional information on antibacterial hand soaps and body washes, we encourage consumers to make an educated choice about what products they choose to use,” said Sandra Kweder, M.D., deputy director, Office of New Drugs at CDER. “Washing with plain soap and running water is one of the most important steps consumers can take to avoid getting sick and to prevent spreading germs to others.”
Consumers should continue to be diligent about washing their hands. If soap and water are not available, an alcohol-based hand sanitizer that contains at least 60 percent alcohol should be used. More information on appropriate hand washing from the CDC may be found here.
Almost all soaps labeled “antibacterial” or “antimicrobial” contain at least one of the antibacterial ingredients addressed in the proposed rule. The most common active ingredients in antibacterial soaps are triclosan and triclocarban. Some soaps labeled “deodorant” may also contain these ingredients.
The proposed rule does not require the antibacterial soap products to be removed from the market at this time. When the proposed rule is finalized, as previously stated, either companies will have provided data to support an antibacterial claim, or if not, they will have to reformulate (remove antibacterial active ingredients) or relabel (remove the antibacterial claim from the product's labeling) these products in order to continue marketing. The proposed rule is available for public comment for 180 days, with a concurrent one year period for companies to submit new data and information, followed by a 60-day rebuttal comment period.
FDA NEWS RELEASE
FDA issues proposed rule to determine safety and effectiveness of antibacterial soaps
The U.S. Food and Drug Administration today issued a proposed rule to require manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Under the proposal, if companies do not demonstrate such safety and effectiveness, these products would need to be reformulated or relabeled to remain on the market.
Today’s action is part of a larger, ongoing review of antibacterial active ingredients by the FDA to ensure these ingredients are proven to be safe and effective. This proposed rule does not affect hand sanitizers, wipes, or antibacterial products used in health care settings.
Millions of Americans use antibacterial hand soap and body wash products. Although consumers generally view these products as effective tools to help prevent the spread of germs, there is currently no evidence that they are any more effective at preventing illness than washing with plain soap and water. Further, some data suggest that long-term exposure to certain active ingredients used in antibacterial products—for example, triclosan (liquid soaps) and triclocarban (bar soaps)—could pose health risks, such as bacterial resistance or hormonal effects.
“Antibacterial soaps and body washes are used widely and frequently by consumers in everyday home, work, school, and public settings, where the risk of infection is relatively low,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “Due to consumers’ extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk.”
The widespread consumer use of antibacterial products, the accumulated scientific information and concerns raised by health care and consumer groups have prompted the FDA to reevaluate what data are needed to classify the active ingredients in consumer antibacterial products as “generally recognized as safe and effective” or GRASE. Under the proposed rule, manufacturers who want to continue marketing antibacterial products will be required to provide the agency with additional data on the products’ safety and effectiveness, including data from clinical studies to demonstrate that these products are superior to non-antibacterial soaps in preventing human illness or reducing infection.
“While the FDA continues to collect additional information on antibacterial hand soaps and body washes, we encourage consumers to make an educated choice about what products they choose to use,” said Sandra Kweder, M.D., deputy director, Office of New Drugs at CDER. “Washing with plain soap and running water is one of the most important steps consumers can take to avoid getting sick and to prevent spreading germs to others.”
Consumers should continue to be diligent about washing their hands. If soap and water are not available, an alcohol-based hand sanitizer that contains at least 60 percent alcohol should be used. More information on appropriate hand washing from the CDC may be found here.
Almost all soaps labeled “antibacterial” or “antimicrobial” contain at least one of the antibacterial ingredients addressed in the proposed rule. The most common active ingredients in antibacterial soaps are triclosan and triclocarban. Some soaps labeled “deodorant” may also contain these ingredients.
The proposed rule does not require the antibacterial soap products to be removed from the market at this time. When the proposed rule is finalized, as previously stated, either companies will have provided data to support an antibacterial claim, or if not, they will have to reformulate (remove antibacterial active ingredients) or relabel (remove the antibacterial claim from the product's labeling) these products in order to continue marketing. The proposed rule is available for public comment for 180 days, with a concurrent one year period for companies to submit new data and information, followed by a 60-day rebuttal comment period.
Thursday, December 12, 2013
FDA ANNOUNCES VOLUNTARY PLAN TO END USE OF SOME ANTIBIOTICS IN FARM ANIMALS
 |
| Photo From FDA Website. |
Phasing Out Certain Antibiotic Use in Farm Animals
The Food and Drug Administration (FDA) is implementing a voluntary plan with industry to phase out the use of certain antibiotics for enhanced food production.
Antibiotics are added to the animal feed or drinking water of cattle, hogs, poultry and other food-producing animals to help them gain weight faster or use less food to gain weight.
Because all uses of antimicrobial drugs, in both humans and animals, contribute to the development of antimicrobial resistance, it is important to use these drugs only when medically necessary. Governments around the world consider antimicrobial-resistant bacteria a major threat to public health. Illnesses caused by drug-resistant strains of bacteria are more likely to be potentially fatal when the medicines used to treat them are rendered less effective.
FDA is working to address the use of “medically important” antibiotics in food-producing animals for production uses, such as to enhance growth or improve feed efficiency. These drugs are deemed important because they are also used to treat human disease and might not work if the bacteria they target become resistant to the drugs’ effects.
“We need to be selective about the drugs we use in animals and when we use them,” says William Flynn, DVM, MS, deputy director for science policy at FDA’s Center for Veterinary Medicine (CVM). “Antimicrobial resistance may not be completely preventable, but we need to do what we can to slow it down.”
FDA is issuing a final guidance document that explains how animal pharmaceutical companies can work with the agency to voluntarily remove growth enhancement and feed efficiency indications from the approved uses of their medically important antimicrobial drug products, and move the therapeutic uses of these products from over-the-counter (OTC) availability to marketing status requiring veterinary oversight.
Once manufacturers voluntarily make these changes, the affected products can then only be used in food-producing animals to treat, prevent or control disease under the order of or by prescription from a licensed veterinarian.
“This action promotes the judicious use of important antimicrobials, which protects public health and, at the same time, ensures that sick and at-risk animals receive the therapy they need,” says CVM Director Bernadette Dunham, DVM, Ph.D. “We realize that these steps represent changes for veterinarians and animal producers, and we have been working to make this transition as seamless as possible.”
Drugs Primarily in Feed
Flynn explains that all the drugs affected by this plan are antibacterial products. They have long been FDA-approved for production (e.g. growth enhancement) purposes as well as for the treatment, control or prevention of animal diseases. Even today, he says, it is not entirely understood how these drugs make animals grow faster. The drugs are primarily added to feed, although they are sometimes added to the animals’ drinking water.
Bacteria evolve to survive threats to their existence. In both humans and animals, even appropriate therapeutic uses of antibiotics can promote the development of drug resistant bacteria. When such bacteria enter the food supply, they can be transferred to the people who eat food from the treated animal.
In 2010, FDA called for a strategy to phase out production use of medically important antimicrobial products and to bring the remaining therapeutic uses under the oversight of a veterinarian. The guidance document that FDA is issuing on Dec. 11, 2013, which was previously issued in draft form in 2012, lays out such a strategy and marks the beginning of the formal implementation period.
The agency is asking animal pharmaceutical companies to notify FDA within the next three months of their intent to voluntarily make the changes recommended in the guidance. Based on timeframes set out in the guidance, these companies would then have three years to fully implement these changes.
To help veterinarians and producers of food-producing animals comply with the new terms of use for these products once the recommended changes are implemented, FDA is proposing changes to the Veterinary Feed Directives (VFD) process. This is an existing system that governs the distribution and use of certain drugs (VFD drugs) that can only be used in animal feed with the specific authorization of a licensed veterinarian. Flynn explains that feed-use antibiotics that are considered medically important and are currently available as OTC products will, as a result of implementation of the guidance document, come under the VFD process.
The proposed changes to the VFD process are intended to clarify the administrative requirements for the distribution and use of VFD drugs and improve the efficiency of the VFD program. Such updates to the VFD process will assist in the transition of OTC products to their new VFD status.
Why Voluntary?
Flynn explains that the final guidance document made participation voluntary because it is the fastest, most efficient way to make these changes. FDA has been working with associations that include those representing drug companies, the feed industry, producers of beef, pork and turkey, as well as veterinarians and consumer groups.
"Based on our outreach, we have every reason to believe that animal pharmaceutical companies will support us in this effort," says Michael R. Taylor, FDA's deputy commissioner for foods and veterinary medicine.
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Tuesday, December 10, 2013
FDA APPROVES NEW DRUG FOR TREATING CHRONIC HEPATITIS C
FROM: U.S. FOOD AND DRUG ADMINISTRATION
For Immediate Release: Dec. 6, 2013
FDA approves Sovaldi for chronic hepatitis C
Drug is third with breakthrough therapy designation to receive FDA approval
The U.S. Food and Drug Administration today approved Sovaldi (sofosbuvir) to treat chronic hepatitis C virus (HCV) infection. Sovaldi is the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon.
“Today’s approval represents a significant shift in the treatment paradigm for some patients with chronic hepatitis C,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
Sovaldi is the second drug approved by the FDA in the past two weeks to treat chronic HCV infection. On November 22, the FDA approved Olysio (simeprevir).
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take several years. Some people with chronic HCV infection develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections or liver cancer. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV.
Sovaldi is a nucleotide analog inhibitor that blocks a specific protein needed by the hepatitis C virus to replicate. Sovaldi is to be used as a component of a combination antiviral treatment regimen for chronic HCV infection. There are several different types of HCV infection. Depending on the type of HCV infection a patient has, the treatment regimen could include Sovaldi and ribavirin or Sovaldi, ribavirin and peginterferon-alfa. Ribavirin and peginterferon-alfa are two drugs also used to treat HCV infection.
Sovaldi’s effectiveness was evaluated in six clinical trials consisting of 1,947 participants who had not previously received treatment for their disease (treatment-naive) or had not responded to previous treatment (treatment-experienced), including participants co-infected with HCV and HIV. The trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response), suggesting a participant’s HCV infection has been cured.
Results from all clinical trials showed a treatment regimen containing Sovaldi was effective in treating multiple types of the hepatitis C virus. Additionally, Sovaldi demonstrated efficacy in participants who could not tolerate or take an interferon-based treatment regimen and in participants with liver cancer awaiting liver transplantation, addressing unmet medical needs in these populations.
The most common side effects reported in clinical study participants treated with Sovaldi and ribavirin were fatigue and headache. In participants treated with Sovaldi, ribavirin and peginterferon-alfa, the most common side effects reported were fatigue, headache, nausea, insomnia and anemia.
Sovaldi is the third drug with breakthrough therapy designation to receive FDA approval. The FDA can designate a drug as a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may demonstrate a substantial improvement over available therapies for patients with serious or life-threatening diseases. Sovaldi was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.
Sovaldi is marketed by Gilead, based in Foster City, Calif. Olysio is marketed by Raritan, N.J.-based Janssen Pharmaceuticals.
For Immediate Release: Dec. 6, 2013
FDA approves Sovaldi for chronic hepatitis C
Drug is third with breakthrough therapy designation to receive FDA approval
The U.S. Food and Drug Administration today approved Sovaldi (sofosbuvir) to treat chronic hepatitis C virus (HCV) infection. Sovaldi is the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon.
“Today’s approval represents a significant shift in the treatment paradigm for some patients with chronic hepatitis C,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
Sovaldi is the second drug approved by the FDA in the past two weeks to treat chronic HCV infection. On November 22, the FDA approved Olysio (simeprevir).
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take several years. Some people with chronic HCV infection develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections or liver cancer. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV.
Sovaldi is a nucleotide analog inhibitor that blocks a specific protein needed by the hepatitis C virus to replicate. Sovaldi is to be used as a component of a combination antiviral treatment regimen for chronic HCV infection. There are several different types of HCV infection. Depending on the type of HCV infection a patient has, the treatment regimen could include Sovaldi and ribavirin or Sovaldi, ribavirin and peginterferon-alfa. Ribavirin and peginterferon-alfa are two drugs also used to treat HCV infection.
Sovaldi’s effectiveness was evaluated in six clinical trials consisting of 1,947 participants who had not previously received treatment for their disease (treatment-naive) or had not responded to previous treatment (treatment-experienced), including participants co-infected with HCV and HIV. The trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response), suggesting a participant’s HCV infection has been cured.
Results from all clinical trials showed a treatment regimen containing Sovaldi was effective in treating multiple types of the hepatitis C virus. Additionally, Sovaldi demonstrated efficacy in participants who could not tolerate or take an interferon-based treatment regimen and in participants with liver cancer awaiting liver transplantation, addressing unmet medical needs in these populations.
The most common side effects reported in clinical study participants treated with Sovaldi and ribavirin were fatigue and headache. In participants treated with Sovaldi, ribavirin and peginterferon-alfa, the most common side effects reported were fatigue, headache, nausea, insomnia and anemia.
Sovaldi is the third drug with breakthrough therapy designation to receive FDA approval. The FDA can designate a drug as a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may demonstrate a substantial improvement over available therapies for patients with serious or life-threatening diseases. Sovaldi was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.
Sovaldi is marketed by Gilead, based in Foster City, Calif. Olysio is marketed by Raritan, N.J.-based Janssen Pharmaceuticals.
Monday, December 2, 2013
FDA GUIDELINES FOR SELECTING SEA FOOD
FROM: U.S. FOOD AND DRUG ADMINISTRATION
Fish and shellfish contain high quality protein and other essential nutrients and are an important part of a healthful diet. In fact, a well-balanced diet that includes a variety of fish and shellfish can contribute to heart health and aid in children’s proper growth and development. As with any type of food, however, it is important to handle seafood safely in order to reduce the risk of foodborne illness, often called “food poisoning.” Follow these basic food safety tips for buying, preparing, and storing fish and shellfish — and you and your family can safely enjoy the fine taste and good nutrition of seafood.
Buy Right
Fresh Fish and Shrimp
Only buy fish that is refrigerated or displayed on a thick bed of fresh ice that is not melting (preferably in a case or under some type of cover).
Fish should smell fresh and mild, not fishy, sour, or ammonia-like.
A fish’s eyes should be clear and bulge a little.
Whole fish and fillets should have firm, shiny flesh and bright red gills free from milky slime.
The flesh should spring back when pressed.
Fish fillets should display no discoloration, darkening or drying around the edges.
Shrimp flesh should be translucent and shiny with little or no odor.
Some refrigerated seafood may have time/temperature indicators on their packaging, which show if the product has been stored at the proper temperature. Always check the indicators when they are present and only buy the seafood if the indicator shows that the product is safe to eat.
Selecting Shellfish
Follow these general guidelines for safely selecting shellfish:
Look for the label: Look for tags on sacks or containers of live shellfish (in the shell) and labels on containers or packages of shucked shellfish. These tags and labels contain specific information about the product, including the processor’s certification number. This means that the shellfish were harvested and processed in accordance with national shellfish safety controls.
Discard Cracked/Broken Ones: Throw away clams, oysters, and mussels if their shells are cracked or broken.
Do a “Tap Test”: Live clams, oysters, and mussels will close up when the shell is tapped. If they don’t close when tapped, do not select them.
Check for Leg Movement: Live crabs and lobsters should show some leg movement. They spoil rapidly after death, so only live crabs and lobsters should be selected and prepared.
Frozen Seafood
Frozen seafood can spoil if the fish thaws during transport and is left at warm temperatures for too long.
Don’t buy frozen seafood if its package is open, torn, or crushed on the edges.
Avoid packages that are positioned above the “frost line” or top of the freezer case.
Avoid packages with signs of frost or ice crystals, which may mean the fish has been stored a long time or thawed and refrozen.
Store Properly
Put seafood on ice or in the refrigerator or freezer soon after buying it. If seafood will be used within 2 days after purchase, store it in the refrigerator. Otherwise, wrap it tightly in plastic, foil, or moisture-proof paper and store it in the freezer.
Fish and shellfish contain high quality protein and other essential nutrients and are an important part of a healthful diet. In fact, a well-balanced diet that includes a variety of fish and shellfish can contribute to heart health and aid in children’s proper growth and development. As with any type of food, however, it is important to handle seafood safely in order to reduce the risk of foodborne illness, often called “food poisoning.” Follow these basic food safety tips for buying, preparing, and storing fish and shellfish — and you and your family can safely enjoy the fine taste and good nutrition of seafood.
Buy Right
Fresh Fish and Shrimp
Only buy fish that is refrigerated or displayed on a thick bed of fresh ice that is not melting (preferably in a case or under some type of cover).
Fish should smell fresh and mild, not fishy, sour, or ammonia-like.
A fish’s eyes should be clear and bulge a little.
Whole fish and fillets should have firm, shiny flesh and bright red gills free from milky slime.
The flesh should spring back when pressed.
Fish fillets should display no discoloration, darkening or drying around the edges.
Shrimp flesh should be translucent and shiny with little or no odor.
Some refrigerated seafood may have time/temperature indicators on their packaging, which show if the product has been stored at the proper temperature. Always check the indicators when they are present and only buy the seafood if the indicator shows that the product is safe to eat.
Selecting Shellfish
Follow these general guidelines for safely selecting shellfish:
Look for the label: Look for tags on sacks or containers of live shellfish (in the shell) and labels on containers or packages of shucked shellfish. These tags and labels contain specific information about the product, including the processor’s certification number. This means that the shellfish were harvested and processed in accordance with national shellfish safety controls.
Discard Cracked/Broken Ones: Throw away clams, oysters, and mussels if their shells are cracked or broken.
Do a “Tap Test”: Live clams, oysters, and mussels will close up when the shell is tapped. If they don’t close when tapped, do not select them.
Check for Leg Movement: Live crabs and lobsters should show some leg movement. They spoil rapidly after death, so only live crabs and lobsters should be selected and prepared.
Frozen Seafood
Frozen seafood can spoil if the fish thaws during transport and is left at warm temperatures for too long.
Don’t buy frozen seafood if its package is open, torn, or crushed on the edges.
Avoid packages that are positioned above the “frost line” or top of the freezer case.
Avoid packages with signs of frost or ice crystals, which may mean the fish has been stored a long time or thawed and refrozen.
Store Properly
Put seafood on ice or in the refrigerator or freezer soon after buying it. If seafood will be used within 2 days after purchase, store it in the refrigerator. Otherwise, wrap it tightly in plastic, foil, or moisture-proof paper and store it in the freezer.
Sunday, December 1, 2013
FDA CONSUMER SAFETY ALERT REGARDING INTERNET SALES OF LASER PRODUCTS
FROM: U.S. FOOD AND DRUG ADMINISTRATION
Radiation-Emitting Products
Consumer Safety Alert: Internet Sales of Laser Products
The Food and Drug Administration (FDA) is aware that some laser products being sold on the internet may not meet federal safety requirements and should not be available for purchase by the general public. In some cases, these products are overpowered and may be unsafe if not used responsibly. In other cases, these products are intended for use only by licensed medical professionals, trained operators, or other approved users.
FDA’s Concerns
FDA is concerned about recent reports of laser products directed at aircraft—a potentially hazardous situation. The agency is particularly concerned about the increased availability of overpowered green laser pointers. Overpowered green laser pointers are those that may have been modified to emit more radiation than the manufacturer’s original product.
What FDA Can Do
FDA’s authority is over the manufacturers of laser products. These products must meet a federal standard for the amount of radiation they can emit and must be properly labeled. FDA is working to identify manufacturers of overpowered green laser pointers and other illegal laser products and will take action to prevent unsafe products from being sold in the United States. If illegal products are imported into the U.S., they may be refused entry, returned to the seller, or destroyed.
Buyer Beware
FDA recommends that consumers be cautious when buying laser products over the internet. Consumers may unknowingly purchase an illegal laser product or may lose their money if the illegal product is refused entry into the U.S. or destroyed.
Consumers should be aware that:
Medical lasers may only be sold to licensed medical practitioners.
Class IIIb and class IV laser light show projectors, identified as such on the label, may only be sold by or to individuals or firms with current, approved laser light show variances from FDA. Laser products that are advertised as uncertified components may only be sold to other manufacturers and may not be sold to the public for general use.
Laser products should have certification and identification labels stating the product complies with the federal laser standard.
Complies with 21 CFR 1040.10 and 1040.11
Complies with 21 CFR Chapter 1, Subchapter J
Manufactured or distributed by...
Date of Manufacture
Products should have a warning label advising the user to avoid exposure to the laser radiation. Consumers who can not verify the above, or do not understand what it means, probably should not sell or purchase the products.
Radiation-Emitting Products
Consumer Safety Alert: Internet Sales of Laser Products
The Food and Drug Administration (FDA) is aware that some laser products being sold on the internet may not meet federal safety requirements and should not be available for purchase by the general public. In some cases, these products are overpowered and may be unsafe if not used responsibly. In other cases, these products are intended for use only by licensed medical professionals, trained operators, or other approved users.
FDA’s Concerns
FDA is concerned about recent reports of laser products directed at aircraft—a potentially hazardous situation. The agency is particularly concerned about the increased availability of overpowered green laser pointers. Overpowered green laser pointers are those that may have been modified to emit more radiation than the manufacturer’s original product.
What FDA Can Do
FDA’s authority is over the manufacturers of laser products. These products must meet a federal standard for the amount of radiation they can emit and must be properly labeled. FDA is working to identify manufacturers of overpowered green laser pointers and other illegal laser products and will take action to prevent unsafe products from being sold in the United States. If illegal products are imported into the U.S., they may be refused entry, returned to the seller, or destroyed.
Buyer Beware
FDA recommends that consumers be cautious when buying laser products over the internet. Consumers may unknowingly purchase an illegal laser product or may lose their money if the illegal product is refused entry into the U.S. or destroyed.
Consumers should be aware that:
Medical lasers may only be sold to licensed medical practitioners.
Class IIIb and class IV laser light show projectors, identified as such on the label, may only be sold by or to individuals or firms with current, approved laser light show variances from FDA. Laser products that are advertised as uncertified components may only be sold to other manufacturers and may not be sold to the public for general use.
Laser products should have certification and identification labels stating the product complies with the federal laser standard.
Complies with 21 CFR 1040.10 and 1040.11
Complies with 21 CFR Chapter 1, Subchapter J
Manufactured or distributed by...
Date of Manufacture
Products should have a warning label advising the user to avoid exposure to the laser radiation. Consumers who can not verify the above, or do not understand what it means, probably should not sell or purchase the products.
Saturday, November 30, 2013
FDA ON REVIEW AND SAFETY OF CELL PHONES
FROM: U.S. FOOD AND DRUG ADMINISTRATION
Cell Phones
Under the law, FDA does not review the safety of radiation-emitting consumer products such as cell phones and similar wireless devices before they can be sold, as it does with new drugs or medical devices. However, FDA does have the authority to take action if cell phones are shown to emit radiofrequency energy (RF) at a level that is hazardous to the user. In such a case, FDA could require cell phone manufacturers to notify users of the health hazard and to repair, replace or recall the phones so that the hazard no longer exists.
Interagency Working Group
FDA belongs to the Radiofrequency Interagency Work Group. The federal agencies in this group have responsibility for different aspects of RF safety and work to ensure coordinated efforts at the federal level. The other agencies in this group are:
National Institute for Occupational Safety and Health
Environmental Protection Agency
Federal Communications Commission
Occupational Safety and Health Administration
National Telecommunications and Information Administration
Federal Communications Commission
FDA shares regulatory responsibilities for cell phones with the Federal Communications Commission (FCC). FCC certifies wireless devices, and all phones that are sold in the United States must comply with FCC guidelines on RF exposure. FCC relies on the FDA and other health agencies on health and safety related questions about cell phones.
FCC also regulates cell phone base stations. These base stations operate at higher power than cell phones. The RF exposures people experience from base stations are typically much lower than from cell phones because base station antennas are mounted on towers or other building structures and are thus substantially farther away from the public. Both cell phones and base stations are required to comply with FCC RF exposure guidelines.
International Workgroup
For the past several years, delegations from Japan, Korea, the European Union, Australia, China, the World Health Organization, and the United States have met to discuss health concerns for wireless telecommunications. The purpose of these workshops has been to discuss scientific issues related to RF exposure from wireless communications technology from an international perspective. Specific topics addressed have included:
health effects of emerging wireless technologies
recent biological research
standards development
prospects for international collaboration related to the safety of wireless telecommunication devices.
Cell Phones
Under the law, FDA does not review the safety of radiation-emitting consumer products such as cell phones and similar wireless devices before they can be sold, as it does with new drugs or medical devices. However, FDA does have the authority to take action if cell phones are shown to emit radiofrequency energy (RF) at a level that is hazardous to the user. In such a case, FDA could require cell phone manufacturers to notify users of the health hazard and to repair, replace or recall the phones so that the hazard no longer exists.
Interagency Working Group
FDA belongs to the Radiofrequency Interagency Work Group. The federal agencies in this group have responsibility for different aspects of RF safety and work to ensure coordinated efforts at the federal level. The other agencies in this group are:
National Institute for Occupational Safety and Health
Environmental Protection Agency
Federal Communications Commission
Occupational Safety and Health Administration
National Telecommunications and Information Administration
Federal Communications Commission
FDA shares regulatory responsibilities for cell phones with the Federal Communications Commission (FCC). FCC certifies wireless devices, and all phones that are sold in the United States must comply with FCC guidelines on RF exposure. FCC relies on the FDA and other health agencies on health and safety related questions about cell phones.
FCC also regulates cell phone base stations. These base stations operate at higher power than cell phones. The RF exposures people experience from base stations are typically much lower than from cell phones because base station antennas are mounted on towers or other building structures and are thus substantially farther away from the public. Both cell phones and base stations are required to comply with FCC RF exposure guidelines.
International Workgroup
For the past several years, delegations from Japan, Korea, the European Union, Australia, China, the World Health Organization, and the United States have met to discuss health concerns for wireless telecommunications. The purpose of these workshops has been to discuss scientific issues related to RF exposure from wireless communications technology from an international perspective. Specific topics addressed have included:
health effects of emerging wireless technologies
recent biological research
standards development
prospects for international collaboration related to the safety of wireless telecommunication devices.
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