FDA mandates warnings, education on use of opioids with benzodiazepines

The Food and Drug Administration (FDA) is taking aim at concurrent use of opioid medications and benzodiazepines. The federal agency announced Aug. 31 that it is requiring new boxed label warnings and patient-focused Medication Guides for nearly 400 prescription opioids, opioid-containing cough medicines and benzodiazepines.

The FDA added in its announcement that because of the unique medical needs of patients who receive medication-assisted treatment for opioid dependence, it will continue to review evidence on the effects of concurrent use of opioids for addiction with benzodiazepines.

An agency data review, coinciding with a petition signed by many state and local public health officials last February, found that the number of patients who were prescribed an opioid and a benzodiazepine jumped 41% from 2002-2014. In addition, overdose deaths involving both medication classes nearly tripled from 2004-2011.

“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,” FDA Commissioner Robert Califf, MD., said in a news release. “We implore health care 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.”