FDA issues sweeping new requirements for long-acting opioids

Drug makers must conduct post-market clinical studies to assess safety

SILVER SPRING, Md. — Companies that make long-acting opioid painkillers will be required to conduct studies to assess their safety, while use of the drugs will be restricted, under new requirements from the Food and Drug Administration.

The agency announced new labeling changes and regulatory requirements for makers of extended-release and long-acting opioids, citing the risk the drugs carry of overdose, abuse and withdrawal. In response, a group also cautioned consumers to be careful when using non-steroidal anti-inflammatory drugs.

Among the changes, the language on the drugs' safety labels will state that they should be used to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment when alternatives are unavailable, but they should not be used on an as-needed basis. In addition, they should be reserved for patients for whom alternatives such as non-opioid drugs are ineffective or unsafe. The drugs were previously indicated for moderate to severe pain in patients requiring continuous, around-the-clock treatment for an extended period of time.

Drugs affected by the decision include Purdue Pharma's OxyContin (oxycodone) and Endo's Opana ER (oxymorphone), as well as other branded and generic drugs in the class.

"The FDA is invoking its authority to require safety labeling changes and post-market 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 Hamburg said. "Today's action demonstrates the FDA's resolve to reduce the serious risks of long-acting and extended-release opioids while seeking to preserve appropriate access for those patients who rely on these medications to manage their pain."

For clinical trials, drug companies will be required to assess known risks of misuse, abuse, increased sensitivity to pain, addiction, overdose and death. Another labeling change will warn that chronic use of the drugs during pregnancy can result in infants having neonatal opioid withdrawal syndrome, a potentially life-threatening condition.

Following the FDA's announcement, the Eugene, Ore.-based Alliance for Rational Use of NSAIDs said that because many health professionals and patients would likely look to prescription and OTC NSAIDs as alternatives for pain management, consumers should use any NSAID at the lowest effective dose for the shortest period of time required to achieve a desired therapeutic outcome.

"Proper use of NSAIDs can save at least 100,000 hospital admissions per year," alliance chairman Byron Cryer said. "The alliance's mission to support safe and effective use of NSAIDs is critical, particularly as the FDA limits the use of extended-release [and] long-acting opioids."


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