US FDA acts on safer use of ER and long-acting opioids

The US Food and Drug Administration yesterday approved a risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioids, highly potent drugs approved for moderate to severe, persistent pain that requires treatment for an extended period.

The REMS is part of a federal initiative to address the prescription drug abuse, misuse, and overdose epidemic. The REMS introduces new safety measures designed to reduce risks and improve the safe use of ER/LA opioids, while ensuring access to needed medications for patients in pain.

“Misprescribing, misuse and abuse of extended-release and long-acting opioids are a critical and growing public health challenge,” said FDA Commissioner Margaret Hamburg, adding: “The FDA’s goal with this REMS approval is to ensure that health care professionals are educated on how to safely prescribe opioids and that patients know how to safely use these drugs.”