FDA to update label warnings on combined opioid, benzodiazepine use

The Food and Drug Administration is taking steps to address the “serious risks” linked to combined use of some opioid medications and a class of drugs commonly used to treat anxiety and insomnia.

The FDA will require boxed warnings — the strongest issued by the agency — and medication guides for nearly 400 opioids, opioid-containing cough products and benzodiazepines to contain information about the risks associated with using the medications at the same time.

Risks of combining the drugs include extreme sleepiness, respiratory depression, coma and death, the FDA said in a news release Wednesday.

“It is nothing short of a public health crisis when you see a substantial increase of avoidable overdose and death related to two widely used drug classes being taken together,” said FDA Commissioner Robert Califf, M.D. “We implore healthcare professionals to heed these new warnings and more carefully and thoroughly evaluate, on a patient-by-patient basis, whether the benefits of using opioids and benzodiazepines — or [central nervous system] depressants more generally — together outweigh these serious risks.”

The FDA announcement comes amid a growing opioid abuse epidemic in the U.S.

On Wednesday, President Barack Obama announced $53 million in grants to states to help fight the epidemic,  including $11 million to expand access to medication-assisted treatment and $11.5 million to help states grow their drug monitoring programs.