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Amid Chronic Pain Prescribing Surge, FDA Changes Benzodiazepine Labeling to Include Abuse, Addiction Warnings

painmedicinenews.com

PainMedicineNews.com

With benzodiazepine prescribing increasing for approved indications and off-label uses, the FDA is taking action to make the use of the drug class safer for patients. The agency announced in a Drug Safety Communication that it is requiring an update to the boxed warning for benzodiazepines to now include the risks for abuse, misuse, addiction, physical dependence, and withdrawal reactions. 

The FDA is also requiring class-wide changes to the Warnings and Precautions, Drug Abuse and Dependence, and Patient Counseling Information sections of the prescribing information for all benzodiazepine products. In parallel, revisions will be made to the existing ...