FDA labels more opioids with black box warning | Behavioral Healthcare Executive Skip to content Skip to navigation

FDA labels more opioids with black box warning

March 22, 2016
by Julie Miller, Editor in Chief
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The U.S. Food and Drug Administration (FDA) today announced new black-box labeling changes for immediate-release (IR) opioid pain medications. The labeling will warn patients about serious risks including addiction, overdose and death.

Black-box warnings are the strongest labels FDA can use and typically indicate a drug has serious risks. State health directors have long petitioned FDA to use such warnings on opioids.

According to FDA, the move is part of the agency’s overall effort to help inform prescribers about balancing the serious risks of opioids with their role in managing pain. Indeed, the agency recently announced a new task force on opioids that will collaborate with clinical experts. Additionally, the recently appointed commissioner, Robert Califf, MD, has promised to support the use of abuse-deterrent formulations among medications approved by FDA.

“Today’s actions are one of the largest undertakings for informing prescribers of risks across opioid products, and one of many steps the FDA intends to take this year as part of our comprehensive action plan to reverse this epidemic,” said Califf, in a statement.

Hard on the heels of a new Centers for Disease Control and Prevention (CDC) voluntary guideline for prescribers, this announcement is reflective of broader federal efforts to improve prescribing practices. Federal leaders are also dedicating additional funding to combat the opioid crisis.

Boxed warning

According to the Washington Post, the new labeling will apply to more than 200 IR products. Extended release medications already have the warning.

For IR opioid analgesics, the FDA now requires a precaution that chronic maternal use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening.

IR products are usually intended for use every four to six hours. The updated indication clarifies that because of known risks, IR opioids should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options are inadequate or not tolerated. The dosing information also provides clearer instructions regarding patient monitoring and drug administration.

Additionally, the FDA is requiring updated labeling for all opioids to include safety information about potentially harmful drug interactions with other medicines that can result in a serious central nervous system condition called serotonin syndrome. FDA issued a Drug Safety Communication outlining these risks.