FDA now requiring boxed warning for benzodiazepines

The FDA is requiring the warning information be updated for benzodiazepines, a class of common psychiatric drugs used to treat generalized anxiety disorder, seizures, insomnia, social phobia and panic disorder.

The agency is mandating an update to benzodiazepines’ boxed warning, the most serious warning that can be placed on a drug label. The labeling must include information on risks of misuse, addiction, physical dependence and withdrawal.

The FDA is also requiring updated information on risks be added to benzodiazepines’ existing patient medication guides.

“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 Sept. 23 news release. “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.”

The agency’s news release said about 92 million benzodiazepine prescriptions were dispensed from U.S. outpatient pharmacies in 2019, with alprazolam (usually prescribed under the brand name Xanax) and clonazepam (usually prescribed under the brand name Klonopin) being dispensed most commonly.

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