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New Boxed Warning for Benzodiazepines

September 23, 2020

The FDA has issued a Drug Safety Communication (DSC) to alert clinicians about updated Boxed Warnings for all benzodiazepines to address the serious risk of abuse, addiction, physical dependence, and withdrawal reactions. These warnings will be included in prescribing information and Medication Guides to help educate patients and caregivers about these risks.

Benzodiazepines are commonly prescribed medicines. In 2019, an estimated 92 million benzodiazepine prescriptions were dispensed from U.S. outpatient retail and mail-order pharmacies, with alprazolam (38%) being the most common followed by clonazepam (24%) and lorazepam (20%).

Post-marketing data suggest that benzodiazepine abuse and misuse are common and that associated harms are substantial but occur primarily when people use benzodiazepines in combination with other drugs. The exact risk of addiction associated with benzodiazepine use is uncertain; however, population data clearly indicate that both primary benzodiazepine use disorders and polysubstance addiction involving benzodiazepines do occur.

The complete Drug Safety Communication can be viewed on the FDA website. Exit Disclaimer: You Are Leaving 

To help the FDA track safety issues with medicines, please report adverse events involving benzodiazepines or other medicines to the MedWatch program as recommended in the Indian Health Manual.Exit Disclaimer: You Are Leaving 

Instructions for reporting can be found online at the NPTC Pharmacovigilance website.