FDA announced the final approval and implementation of labelling changes to address the opioid crisis and also to urge health care professionals to practice patient safety when prescribing opioid analgesic products. 

FDA informed application holders of the safety labelling updates for opioid drugs (both immediate release (IR) and extended release (ER) or long acting (LA) .

The required safety labeling updates, originally listed in an April 2023  Drug Safety Communication, include the addition of language stating:

         the risk of overdose increases as the dosage increases for all opioid pain medicines;           IR opioids should not be used for an extended period of time unless a patient’s pain remains          severe enough to require them and alternative treatment options continue to be inadequate;          many acute pain conditions treated in the outpatient setting require no more than a few days of an opioid pain medicine; and          it is recommended to reserve ER/LA opioid pain medicines for severe and persistent pain that requires an extended treatment period with a daily opioid pain medicine and for which alternative treatment options are inadequate.

The new updates also include warning about opioid- induced hyperalgesia (OIH), a condition in which opioid use causes an increase in pain or an increased sensitivity to pain (allodynia).

The warning also includes information on differentiating OIH symptoms from those of opioid tolerance and withdrawal. 

“While FDA understands the importance of ensuring patients continue to have access to opioid analgesics in their pain management regimens, we believe it is equally important to ensure that patients and prescribers are fully aware of all the benefits and risks of treatment with opioid pain medicines,” said Patrizia Cavazzoni, M.D., Director of the Center for Drug Evaluation and Research. “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.”

FDA’s approval of these labeling updates is a testament to the agency’s continuing progress towards implementing the FDA Overdose Prevention Framework, which provides our vision to undertake impactful, creative actions to prevent drug overdoses and reduce deaths.

Reference

https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-safety-labeling-changes-opioid-pain-medicines

Published On: 01-05-2024