FDA changes benzodiazepine labeling to include abuse, addiction warnings

The U.S. Food and Drug Administration announced new labeling changes for benzodiazepines, warning users of potential abuse, misuse and addiction, according to a Sept. 23 press release.

The boxed warning is part of the FDA's ongoing work to minimize the risks associated with substance abuse, the statement said. Benzodiazepines, which are usually prescribed for generalized anxiety disorder, insomnia, seizures, social phobia and panic disorder, can cause physical dependence after being taken steadily for several days to weeks. About 92 million benzodiazepine prescriptions were dispensed from U.S. outpatient pharmacies in 2019. 

"While benzodiazepines are important therapies for many Americans, they are also commonly abused and misused, often together with opioid pain relievers and other medicines, alcohol and illicit drugs," FDA Commissioner Stephen Hahn, MD, said in a statement. "We are taking measures and requiring new labeling information to help health care professionals and patients better understand that while benzodiazepines have many treatment benefits, they also carry with them an increased risk of abuse, misuse, addiction and dependence."

Read the full press release from the FDA here.

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