GENERIC CELEBREX APPROVED BY FDA FOR ARTHRITIS, OSTEOARTHRITIS

FROM:  U.S. FOOD AND DRUG ADMINISTRATION 

FDA approves first generic versions of celecoxib

May 30, 2014

Release

The U.S. Food and Drug Administration today approved the first generic versions of Celebrex (celecoxib) capsules, a treatment for rheumatoid arthritis, osteoarthritis, short-term (acute) pain, and other conditions.

Teva Pharmaceutical Industries received approval to market celecoxib capsules in 50 milligram, 100 mg, 200 mg, and 400 mg strengths, and has 180-day exclusivity on the 100 mg, 200 mg, and 400 mg strength products. Mylan Pharmaceuticals, Inc. received approval to market 50 mg celecoxib capsules.

“It is important for patients to have access to affordable treatment options for chronic conditions,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Health care professionals and patients can be assured that these FDA-approved generic drugs have met our rigorous approval standards.”

Celecoxib is a Non-Steroidal Anti-Inflammatory Drug (NSAID). All NSAIDs have a Boxed Warning in their prescribing information (label) to alert health care professionals and patients about the risk of heart attack or stroke that can lead to death. This chance increases for people with heart disease or risk factors for it, such as high blood pressure, or taking NSAIDs for long periods of time. The Boxed Warning also highlights the risk of serious, potential life-threatening gastrointestinal (GI) bleeding that has been associated with use of NSAIDs.

In the clinical trials for Celebrex, the most commonly reported adverse reactions in patients taking the drug for arthritis were abdominal pain, diarrhea, indigestion (dyspepsia), flatulence, swelling of the feet or legs (peripheral edema), accidental injury, dizziness, inflammation of the throat (pharyngitis), runny nose (rhinitis), swollen nasal passages, (sinusitis), upper respiratory tract infection, and rash.

Generic prescription drugs approved by the FDA have the same high quality and strength as brand-name drugs. Generic drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.

Information about the availability of generic celecoxib can be obtained from the companies.

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.

ANTIBIOTICS LINKED TO CHILDREN'S DIARRHEA

FROM:  CENTERS FOR DISEASE CONTROL AND PREVENTION 
Severe diarrheal illness in children linked to antibiotics prescribed in doctor’s offices

CDC urges physicians to improve prescribing practices to reduce harm
The majority of pediatric Clostridium difficile infections, which are bacterial infections that cause severe diarrhea and are potentially life-threatening, occur among children in the general community who recently took antibiotics prescribed in doctor’s offices for other conditions, according to a new study by the Centers for Disease Control and Prevention published this week in Pediatrics.
The study showed that 71 percent of the cases of C. difficile infection identified among children aged 1 through 17 years were community-associated—that is, not associated with an overnight stay in a healthcare facility.  By contrast, two-thirds of C. difficile infections in adults are associated with hospital stays.
Among the community-associated pediatric cases whose parents were interviewed, 73 percent were prescribed antibiotics during the 12 weeks prior to their illness, usually in an outpatient setting such as a doctor’s office.  Most of the children who received antibiotics were being treated for ear, sinus, or upper respiratory infections. Previous studies show that at least 50 percent of antibiotics prescribed in doctor’s offices for children are for respiratory infections, most of which do not require antibiotics.

Improved antibiotic prescribing is critical to protect the health of our nation’s children,” said CDC Director Tom Frieden, M.D., M.P.H.  “When antibiotics are prescribed incorrectly, our children are needlessly put at risk for health problems including C. difficile infection and dangerous antibiotic resistant infections.”
he FY 2015 President’s Budget requests funding for CDC to improve outpatient antibiotic prescribing practices and protect patients from infections, such as those caused by C. difficile.  The CDC initiative aims to reduce outpatient prescribing by up to 20 percent and healthcare-associated C. difficile infections by 50 percent in five years.  A 50 percent reduction in healthcare-associated C. difficile infections could save 20,000 lives, prevent 150,000 hospitalizations, and cut more than $2 billion in healthcare costs.

C. difficile, which causes at least 250,000 infections in hospitalized patients and 14,000 deaths every year among children and adults, remains at all-time high levels.  According to preliminary CDC data, an estimated 17,000 children aged 1 through 17 years get C. difficile infections every year.  The Pediatrics study found that there was no difference in the incidence of C. difficile infection among boys and girls, and that the highest numbers were seen in white children and those between the ages of 12 and 23 months.

Taking antibiotics is the most important risk factor for developing C. difficile infections for both adults and children.  When a person takes antibiotics, beneficial bacteria that protect against infection can be altered or even eliminated for several weeks to months. During this time, patients can get sick from C. difficile picked up from contaminated surfaces or spread from a health care provider’s hands.
Although there have been significant improvements in antibiotic prescribing for certain acute respiratory infections in children, further improvement is greatly needed.  In addition, it is critical that parents avoid asking doctors to prescribe antibiotics for their children and that doctors follow prescribing guidelines.
“As both a doctor and a mom, I know how difficult it is to see your child suffer with something like an ear infection,” said Lauri Hicks, DO, Adobe PDF file director of CDC’s Get Smart: Know When Antibiotics Work program. “Antibiotics aren’t always the answer. I urge parents to work with their child’s doctor to find the best treatment for the illness, which may just be providing symptom relief.”

SWIMMING POOL OR TOILET? YOU DECIDE

Photo Credit:  Wikimedia.

FROM: CENTERS FOR DISEASE CONTROL AND PREVENTION

CDC study finds fecal contamination in pools
A study of public pools done during last summer’s swim season found that feces are frequently introduced into pool water by swimmers. Through the study, released today by the Centers for Disease Control and Prevention (CDC), researchers found germs in samples of pool filter water collected from public pools.

CDC collected samples of water from pool filters from public pools and tested the samples for genetic material (for example, DNA) of multiple microbes. The study found that 58 percent of the pool filter samples tested were positive for E. coli, bacteria normally found in the human gut and feces. The E. coli is a marker for fecal contamination.

Finding a high percentage of E. coli-positive filters indicates swimmers frequently contaminate pool water when they have a fecal incident in the water or when feces rinse off of their bodies because they do not shower thoroughly before getting into the water. No samples tested positive for E. coli O157:H7, a toxin-producing E. coli strain that causes illness.

Pseudomonas aeruginosa, whichcan cause skin rashes and ear infections, was detected in 59 percent of samples. Finding Pseudomonas aeruginosa in the water indicates natural environmental contamination or contamination introduced by swimmers. Cryptosporidium and Giardia, germs that are spread through feces and cause diarrhea, were found in less than 2 percent of samples. The tests used in the study do not indicate whether the detected germs were alive or able to cause infections. Indoor and outdoor public pools were sampled.

The study did not address water parks, residential pools or other types of recreational water. The study does not allow CDC to make conclusions about all pools in the United States. However, it is unlikely that swimmer-introduced contamination, or swimmer hygiene practices, differ between pools in the study and those in the rest of the country.

"Swimming is an excellent way to get the physical activity needed to stay healthy," said Michele Hlavsa, chief of CDC’s Healthy Swimming Program. "However, pool users should be aware of how to prevent infections while swimming. Remember, chlorine and other disinfectants don’t kill germs instantly. That’s why it’s important for swimmers to protect themselves by not swallowing the water they swim in and to protect others by keeping feces and germs out of the pool by taking a pre-swim shower and not swimming when ill with diarrhea."

This study is presented in recognition of Recreational Water Illness and Injury Prevention Week, May 20–26, 2013. The goal of the prevention week is to raise awareness about healthy swimming, including ways to prevent recreational water illnesses (RWIs). Germs that cause RWIs are spread by swallowing, breathing in the mists or aerosols from, or having contact with contaminated water in swimming pools, water parks, hot tubs, interactive fountains, water play areas, lakes, rivers, or oceans.

BEACH SAND DIARRHEA

Photo Credit:  EPA

FROM:  U.S. ENVIRONMENTAL PROTECTION AGENCY
Digging in beach sand linked to increased risk of gastrointestinal illness

People take certain precautions when they go to the beach. They apply sunscreen to avoid sunburn and stay away from big waves if they are not strong swimmers. But they do not usually worry about getting sick from digging or playing in the sand.

Unfortunately, beach sand could harbor even more harmful bacteria than nearby bathing waters. EPA researchers and their counterparts at the University of North Carolina at Chapel Hill and Johns Hopkins University observed a positive relationship between sand exposure and gastrointestinal (GI) illnesses as a function of fecal microbial pollution in beach sand.

The study was published in the January 2012 issue of Epidemiology.

In one of the first studies to show this association, the researchers analyzed 144 wet sand samples collected from Fairhope Municipal Park Beach in Fairhope, AL, and Goddard Memorial State Park Beach in Warwick, RI. Both beaches are located less than 2 miles from a publicly owned waste treatment-works outfall. The researchers then tested the samples for bacterial indicators of fecal contamination, namely, Enterococcus, Bacteroidales, fecal Bacteroides, and Clostridium, as well as a viral indicator called F+ coliphage.The researchers also asked 4,999 people who visited these beaches about their contact with beach sand and their swimming behaviors and other beach activities. Approximately 2 weeks later, they called the participants and asked them about any diarrhea, vomiting, nausea, and/or stomach ache that they and other members of their household may have experienced. Too, they asked about activities that might have taken place since the initial interview, such as going back to same beach, swimming in a pool, or eating raw or undercooked foods.

They found that, compared with beachgoers who did not dig in the sand, the adjusted odds ratio (OR) of illness among those who dug in the sand with the highest Enterococcus levels was 2.0 for GI illnesses and 2.4 for diarrhea (considered as a separate outcome). An OR of 1 implies that the event is equally likely to occur in both groups, and an OR of greater than 1 implies that the event is more likely to occur in the first group (those who dug in the sand).

The researchers also observed positive associations between Bacteroidales and diarrhea among those who reported digging in the sand and being buried in the sand. For Bacteroidales and other fecal indicators, being buried in the sand generally showed a somewhat stronger association with GI illness and diarrhea than did just digging in the sand.

The researchers noted that it is possible that the associations between sand contact and GI illness reflect exposure to contaminated water as well as sand. Teasing apart these effects is challenging because the study showed that very few people who played in sand had no recreational water contact. Eighty-one percent of swimmers versus 19% of nonswimmers reported digging in the sand, whereas 89% of swimmers versus 11% of nonswimmers reported being buried in it.

"We have known for some time that swimming in fecally contaminated water is a risk factor for gastrointestinal symptoms, but this is the first analysis to link these symptoms to measures of fecal contamination in sand," said EPA Environmental Public Health Division (EPHD) Epidemiology Branch Chief Timothy Wade Ph.D., senior author of the study. "The symptoms we observed are usually mild and should not deter people from enjoying the beach, but they should consider washing their hands or using a hand sanitizer after playing in the sand or water."

The study was led by EPA then predoctoral trainee Christopher Heaney, Ph.D., now an Assistant Professor of Environmental Health Sciences and Epidemiology at the Johns Hopkins Bloomberg School of Public Health. Other EPA researchers who participated in the study include EPHD health scientist and epidemiologist Elizabeth Sams, MSHSA, and Alfred Dufour of the National Exposure Research Laboratory in Cincinnati.