FDA: Stronger Warnings Needed for Combining Benzodiazepines and Opioids

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.


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