US FDA Requiring Labeling Changes for Benzodiazepines

The U.S. Food and Drug Administration announced today in a Drug Safety Communication that it is requiring an update to the Boxed Warning, the agency’s most prominent safety warning, and requiring class-wide labeling changes for benzodiazepines to include the risks of abuse, misuse, addiction, physical dependence and withdrawal reactions to help improve their safe use.

In 2019, an estimated 92 million benzodiazepine prescriptions were dispensed from U.S. outpatient pharmacies, with alprazolam (38%) being the most common followed by clonazepam (24%) and lorazepam (20%). In 2018, an estimated 50% of patients dispensed oral benzodiazepines received them for two months or longer. Most benzodiazepines are recommended for use for periods of weeks or months. Benzodiazepines are important approved treatment options for generalized anxiety disorder, insomnia, seizures, social phobia and panic disorder. They are also used as premedication before some medical procedures. The dose, frequency and duration of treatment vary depending on the patient, the particular benzodiazepine being prescribed and the medical condition that the drug is being used to treat.

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