Extended-release and long-acting (ER/LA) opioid pain relievers are no longer indicated for merely moderate pain, the US Food and Drug Administration (FDA) announced today as part of a sweeping move to stem the deadly misuse and abuse of the drugs.
Previously, the labels for ER/LA opioid analgesics stated that they were indicated for "moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time." The labels now will state that the drugs are indicated "for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate."
In addition, the labels will include a boxed warning stating that long-term maternal use of ER/LA opioid pain relievers can result in potentially fatal neonatal opioid withdrawal syndrome.
The FDA will require manufacturers of these drugs to perform more studies and clinical trials to "further assess the known risks" of misuse, abuse, hyperalgesia, addiction, overdose, and death.
"The FDA is invoking its authority to require safety label changes and postmarket studies to combat the crisis of misuse, abuse, addiction, overdose, and death from these potent drugs that have harmed too many patients and devastated too many families and communities," said FDA Commissioner Margaret Hamburg, MD, in a news release.
The FDA announcement comes roughly a year after a coalition of 37 physicians, including pain management and addiction experts, asked the agency to tighten label restrictions for opioid analgesics — and remove the indication for moderate noncancer pain — to combat the epidemic of addiction and fatal overdoses associated with these drugs.