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# FDA Requires Warning of Opioid/Benzodiazepine Risks
- URL: https://www.fdaweb.com/fda-requires-warning-of-opioid-benzodiazepine-risks/
- Published: 2016-08-31T12:00:00.000Z
- Updated: 2026-09-14T21:28:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136668

FDA says it is requiring class-wide changes to drug labeling to inform healthcare providers and patients about the serious risks associated with combined use of certain opioids and benzodiazepines. An agency [statement](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm518697.htm?ref=fdaweb.com) says that a Boxed Warning will be required, along with Medication Guides, for nearly 400 prescription opioid analgesics, opioid-containing cough products, and benzodiazepines. The labeling changes cover risks including extreme sleepiness, respiratory depression, coma, and death.

“FDA’s data review showed that physicians have been increasingly prescribing \[the two drugs\] together, and this has been associated with adverse outcomes,” the statement says. Among the data reviewed, the agency concluded that from 2004 to 2011, the rate of emergency department visits involving non-medical use of both drug classes increased significantly, with overdose deaths involving both drug classes nearly tripling during that period. The number of patients who were prescribed both an opioid analgesic and a benzodiazepine increased by 41% between 2002 and 2014, or an increase of more than 2.5 million opioid analgesic patients receiving benzodiazepines.