FDA: Stronger Warnings Needed for Combining Benzodiazepines and Opioids

By Kristin J. Kelley

Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, FASAM

The FDA is requiring boxed warnings for nearly 400 medications, including prescription opioid painkillers (e.g., hydrocodone, morphine, oxycodone), opioid-containing cough medicines, and benzodiazepines.

When used in combination, opioids and benzodiazepines are associated with risks for respiratory depression, coma, and death.

The agency's action follows a citizen petition filed in February by public health officials asking for changes to existing labels.

Patients are often prescribed benzodiazepines and opioids together, according to an FDA review. Data show a 41% increase in coprescriptions between 2002 and 2014. Additionally, overdose deaths from prescribed or greater-than-prescribed doses of benzodiazepines and opioids almost tripled from 2004 to 2011.