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Wednesday, September 11, 2013

FDA Changes Labeling and Study Requirements for Long-Acting Opioids

The U.S. Food and Drug Administration (FDA) announced yesterday that it would be changing the labeling and post-market study requirements for extended-release and long-acting opioid analgesics, in response to the growing rates of addiction and overdose from these drugs.


     “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,” said FDA Commissioner Margaret A. Hamburg, MD, in a press release.


     These actions, according to the FDA, are meant to address the serious risks of these drugs, while continuing to offer the medications as an option for patients who need them to control serious pain.

      The new labeling, when finalized, will include language to aid health care professionals in prescribing decisions for varied patients. For example, the new indication states that these drugs “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.” Additionally, these drugs should be used only in those patients for whom non-opioid analgesics or immediate-release opioids are “ineffective, not tolerated, or otherwise inadequate” for pain management, the new language states.

      The FDA is also requiring pharmaceutical companies who produce these extended-release and long-acting opioids to conduct further clinical trials and postmarket studies in order to address “known serious risks of misuse, abuse, increased sensitivity to pain (hyperalgesia), addiction, overdose, and death.”


      The medications will wear a new boxed warning against chronic maternal use of these drugs during pregnancy because of potentially life-threatening side effects for the fetus, such as neonatal opioid withdrawal syndrome (NOWS). The Risk Evaluation and Mitigation Strategy (REMS) will also be amended once these labeling changes have been completed.

      “The FDA remains committed to improving the safety of opioids and to continuing to engage in efforts to evaluate and mitigate the risks associated with opioid use,” said Douglas Throckmorton, MD, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research.

     For the full press release, visit the FDA’s site: See Neurology Today’s previous coverage of opioid misuse:

      Stay tuned for an in-depth story on these changes to opioid labeling and study requirements in an upcoming issue of Neurology Today.