FDA changing packaging warning for benzodiazepine products

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The U.S. Food and Drug Administration (FDA) recently said it is requiring class-wide changes to the safety warning labeling for benzodiazepines.

The revision will include the risks of abuse, misuse, and addiction, as well as the signs of physical dependence and withdrawal.

The agency also is requiring updates to existing patient medication guides for benzodiazepine products and the warnings and precautions, drug abuse and dependence, and patient counseling information sections of the prescribing information.

These changes are part of the agency’s effort to minimize inappropriate use of controlled substances.

“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 M. Hahn said. “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.”

Approximately 92 million benzodiazepine prescriptions were dispensed last year from outpatient pharmacies in the United States. The most common benzodiazepine was alprazolam, 38 percent of prescriptions, followed by clonazepam, 24 percent, and lorazepam, 20 percent.

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