FDA Requires New Addiction Warning On Benzodiazepines

The U.S. Food and Drug Administration (FDA) is requiring labeling changes for benzodiazepines to include the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions. The update will be included in the Boxed Warning, which is the FDA’s most prominent safety warning. The goal is to help health care professionals and consumers better understand the risks of benzodiazepines, which include diazepam (Valium), alprazolam (Xanax), and clonazepam (Klonopin), among others. During 2019, outpatient pharmacies in the United States dispensed an estimated 92 million benzodiazepine prescriptions.

In addition to requiring an update to the Boxed Warning, the FDA is . . .