FDA Announces Safety Label Changes on Painkiller Meds

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iStockphoto/Thinkstock(WASHINGTON) — The U.S. Food and Drug Administration this week announced changes to safety labels on extended-release and long-acting (ER/LA) opioid analgesics. Opiates can be life-saving for patients with severe pain, but need can turn into addiction, and prescription drugs can kill. The FDA thinks new labeling might have an impact on how doctors prescribe painkillers, and hopefully cut addiction and overdose rates.

“The FDA is invoking its authority to require safety labeling changes and postmarket studies to combat the crisis of misuse, abuse, addiction, overdose, and death from these potent drugs that have harmed too many patients and devastated too many families and communities,” FDA Commissioner Margaret A. Hamburg, M.D., said in an agency release. “Today’s action demonstrates the FDA’s resolve to reduce the serious risks of long-acting and extended release opioids while still seeking to preserve appropriate access for those patients who rely on these medications to manage their pain.”

Painkiller abuse is a growing problem. In 2010, overdoses claimed more than 16,000 lives in the U.S. alone.  

The changes, when final, will include new language that will help health care professionals tailor their prescribing decisions based on individual patient needs. While the FDA changes do not limit dose or duration, it’s just a reminder to doctors of the addiction risks and the potential for abuse.  

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