CDC REPORTS DEATHS INVOLVING OPIOID ANALGESICS IN NEW YORK STATE

FROM:  U.S. CENTERS FOR DISEASE CONTROL AND PREVENTION
Poisoning Deaths Involving Opioid Analgesics — New York, 2003 – 2012

The increase in opioid-analgesics-related mortality across all demographic categories is a serious public health threat in New York State, as it is in the rest of the nation. Statewide efforts are needed to prevent the abuse of prescription medications. As in the United States as a whole, deaths involving opioid analgesics in New York state have dramatically increased over the last decade, from 179 deaths (0.93 per 100,000) in 2003 to 883 (4.51 per 100,000) in 2012. Rates of deaths involving opioid analgesics increased among all groups examined and were consistently highest among men, whites, those ages 45-64 years, and Medicaid enrollees. Multiple drug involvement is characteristic of these deaths. In 2012, 70.7% of deaths involving opioid analgesics also involved at least one other drug, most frequently a benzodiazepine.

NEW FDA ANNOUNCEMENT REGARDING TREATMENT OF PAIN WITH OPIOID ANALGESICS

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.

The U.S. Food and Drug Administration announced class-wide safety labeling changes and new postmarket study requirements for all extended-release and long-acting (ER/LA) opioid analgesics intended to treat pain.

Given the serious risks of using ER/LA opioids, the class-wide labeling changes, when final, will include important new language to help health care professionals tailor their prescribing decisions based on a patient’s individual needs.

The updated indication states that ER/LA opioids are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

The updated indication further clarifies that, because of the risks of addiction, abuse, and misuse, even at recommended doses, and because of the greater risks of overdose and death, these drugs should be reserved for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain; ER/LA opioid analgesics are not indicated for as-needed pain relief.