FDA Approves Labeling Changes For Long-Acting Opioids

The FDA announced on April 16, 2014, that it has approved classwide labeling changes for all extended-release and long-acting (ER/LA) opioid analgesics. The changes were originally announced in September 2013.

The updated indication for the medications states that they are indicated for pain severe enough to require daily, around-the-clock long-term opioid treatment for which alternative therapies are inadequate. Due to the risk of addiction, abuse, and misuse of ER/LA opioid analgesics, the FDA notes that they should be reserved for patients in whom alternatives such as nonopioid analgesics or immediate-release opioids have been not tolerated or ineffective in managing pain.

In addition, ER/LA opioid analgesics will need to bear a new boxed warning cautioning that long-term maternal use during pregnancy can lead to neonatal opioid withdrawal syndrome, which can be life-threatening.

According to the FDA, its goal in requiring the labeling changes is to reduce the risks of ER/LA opioid analgesics while maintaining appropriate access to those who need them to manage pain.