To combat the misuse and abuse of extended-release and long-acting (ER/LA) opioids, Food and Drug Administration (FDA) is announcing class-wide label changes to ER/LA opioids, including a statement indicating the medications should be prescribed when the patient requires constant treatment of severe pain and when alternative methods are inadequate. The label would also warn against the use of ER/LA opioids for as-needed pain relief. The requirements also include a new boxed warning for pregnant women indicating that use of ER/LA opioids during pregnancy can result in neonatal opioid withdrawal syndrome, which can be life-threatening. Symptoms include poor feeding, rapid breathing, trembling, and excessive or high-pitched crying. FDA also sent letters to manufacturers of ER/LA opioids mandating post-market research on the medications in order to “assess the serious risks associated with long-term use of ER/LA opioids” including misuse, abuse, hyperalgesia, addiction, overdose, and death.

In a recent blog post, FDA Commissioner Margaret Hamburg, MD, indicated that the changes put a greater emphasis on the risks ER/LA opioids pose to newborns, but also highlight the importance of physician-patient communication.

Once the changes are finalized, modifications will be made to the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS), to reflect the updated information. Originally approved in 2012, the ER/LA Opioid Analgesics REMS requires companies to make available to health care providers educational programs on how to safely prescribe ER/LA opioid analgesics and to provide Medication Guides and patient counseling documents containing information on the safe use, storage, and disposal of ER/LA opioids.