FDA will require black box warning on immediate-release opioid analgesics

Agency steps up efforts to address opioid addiction and overdose epidemic

FDA announced on March 22 that all immediate-release opioid analgesics must carry a black box warning about the serious risks of misuse, abuse, addiction, overdose, and death.

The announcement comes on the heels of efforts from other federal agencies to educate prescribers and patients about the potential risks related to opioid use. More than 40 Americans die each day from prescription opioid overdoses, according to CDC.

The new boxed warning is part of FDA’s plan to address the crisis—with policies the agency said are aimed at reversing the epidemic while still providing patients in pain access to effective relief.

In a press announcement, Robert Califf, MD, FDA commissioner, said FDA’s actions are one of the largest undertakings for informing prescribers of the risks of all opioid products, and one of many steps FDA intends to take this year as part of its comprehensive action plan to reverse the epidemic.

FDA will require labels for immediate-release opioid analgesics, which are taken every 4 to 6 hours, to indicate that they be prescribed when there are no alternative treatments. Dosing information on labels will also be clearer about patient monitoring and administration.

Other safety labeling requirements in the plan for immediate-release opioid analgesics include noting that chronic maternal use of opioids during pregnancy can cause neonatal opioid withdrawal syndrome.

FDA said the changes are similar to those they issued in 2013 for extended-release painkillers, which contain higher doses and are taken once or twice daily. Those changes included modifications to the products’ indications and limitations of use as well as boxed warnings to communicate the serious risks associated with the drugs.