To that end, the agency is requiring that nearly 400 products carry a "black box warning" highlighting the risks from combined use, it said in a press releaseWednesday. The risks include extreme sleepiness, respiratory depression, coma and death.
The move comes after an extensive review of scientific evidence by the FDA showing that physicians have been increasingly prescribing these drugs together. There was also a request for action in February, when health officials in cities and states across the country petitioned the agency for the change to the drug labels, citing an increase in overdoses from simultaneous use of the drugs.
"As an emergency physician, I have seen so many patients who are prescribed opioids and benzodiazepines together," wrote Dr. Leana Wen, Baltimore's health commissioner and a leader of the effort, on Twitter Wednesday. "A black box warning is a powerful education tool and thank [you to the FDA] for taking action to help prevent deaths from this dangerous combination."