FDA beefs up warning labels for prescription opioids

By Matt Kuhrt

In response to the worsening opioid addiction crisis, the U.S. Food and Drug Administration (FDA) announced a set of changes to labeling requirements for a range of prescription painkillers, with a particular focus on immediate-release formulations.

The country's opioid epidemic has led to increased scrutiny of the role doctors have played in prescribing the painkillers that can get people hooked, leading to difficult choices for physicians under pressure to limit those prescriptions, according to recent coverage by FiercePracticeManagement.

The FDA's latest response beefs up warning labels on prescription opioids by including a "black box" designed to increase patients' awareness of the risks associated with their medication, as well as to guide doctors as they balance the risks and benefits of prescribing opioid painkillers.

For immediate-release opioids, the changed labeling includes a clarification that the product "be reserved for pain severe enough to require opioid treatment and for which alternative treatment options . . . are inadequate or not tolerated." The agency also added language about the risk of neonatal opioid withdrawal syndrome when the drugs are used during pregnancy.

For prescription opioids generally, the FDA now requires that labels provide information on "potentially harmful drug interactions" related to serotonin syndrome. Black box warnings about interactions with benzodiazepine sedatives, which some health advocates have urgently requested, are still under review at the agency, according to the announcement.

Meanwhile, following the lead of communities that have set up safe havens for heroin users to come down off their high under medical observation, NPR reports that the mayor of Ithaca, New York, is now seeking to provide users a facility in which to inject the drugs under supervised conditions.

To learn more:
- see the FDA's announcement
- read the NPR article