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FDA Requiring Labeling Changes to Benzodiazepine Prescribing Information - Update to Boxed Warning Must Include Risks for Abuse, Misuse, Addiction, Physical Dependence, Withdrawal Reaction

FRIDAY, Sept. 11, 2020 (HealthDay News) -- In response to reports of misuse and abuse of benzodiazepines, the U.S. Food and Drug Administration is now requiring class-wide labeling changes to the prescribing information, the agency announced yesterday.

The Boxed Warning on labels for benzodiazepines, including alprazolam, clonazepam, and lorazepam, must be updated to include the risks for abuse, misuse, addiction, physical dependence, and withdrawal reactions. "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, M.D., said in an agency news release.

According to the FDA, an estimated 92 million benzodiazepine prescriptions were dispensed from outpatient pharmacies in 2019. Thirty-eight percent of the prescriptions were for alprazolam, 24 percent for clonazepam, and 20 percent for lorazepam. The agency also noted that an estimated 50 percent of patients who were prescribed oral benzodiazepines in 2018 used them for two months or longer.

Patients can become physically dependent on benzodiazepines when they take them steadily for several days or weeks, and they can experience withdrawal signs or symptoms when stopping the medication abruptly or reducing the dosage too quickly.

The FDA is further requiring changes to the Warnings and Precautions, Drug Abuse and Dependence, and Patient Counseling Information sections of the prescribing information for all benzodiazepines. Existing patient Medication Guides must also be revised to inform patients and caregivers about the risks.

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