In September 2020, the U.S. Food and Drug Administration announced a requirement that the Boxed Warning and other sections of benzodiazepine drug products’ labeling be updated to provide a more comprehensive description of risks related to nonmedical use, addiction, physical dependence, and withdrawal reactions. Benzodiazepine nonmedical use is widespread, and individuals frequently co-use benzodiazepines with alcohol, prescription opioids, and illicit drugs. Associated harms of benzodiazepine nonmedical use are substantial but occur primarily when people use benzodiazepines in combination with other drugs.
This two-day public workshop will convene regulators, academic researchers, clinicians, patient advocates, and other stakeholders to share information underlying this action and gather input related to the safe use of benzodiazepines. Participants will discuss epidemiological and abuse liability data, patient and clinician perspectives and experiences, and gaps in data and understanding about the safe use of benzodiazepines.
Funding for this workshop was made possible in part by a cooperative agreement from the U.S. Food and Drug Administration Center for Drug Evaluation and Research. The views expressed in written workshop materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services nor does mention of trade names, commercial practices, or organizations imply endorsements by the U.S. Government.