FDA approves safety labeling changes for opioids

FDA gave final approval to required safety labeling updates for opioids. The updates, first included in an April 2023 drug safety communication, include the addition of language stating the risk of overdose increases with higher doses for all opioid analgesics and that immediate-release opioids should not be used for an extended period of time unless a patient’s pain is so severe that it cannot be controlled otherwise.

In addition, FDA noted that many acute pain conditions treated in the outpatient setting require no more than a few days’ worth of an opioid analgesic, and that it is recommended to reserve extended-release/long-acting opioids for severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.

The updates also include a new warning about opioid-induced hyperalgesia (OIH) and information differentiating symptoms of OIH from those of opioid tolerance and withdrawal.

“Approving these class-wide labeling updates facilitates safer use of these medicines and furthers our goal to reduce the risks of nonmedical use and overdose,” said Patrizia Cavazzoni, MD, director of FDA’s Center for Drug Evaluation and Research, in a press statement.