USA – FDA updates benzodiazepine boxed warning

The US. Food and Drug Administration (FDA) is requiring that the boxed warning on benzodiazepines be updated to provide a uniform description of the risks associated with all medications in the class.

On 23 September 2020, FDA announced in a Drug Safety Communication that current prescribing information for benzodiazepines « does not provide adequate warnings about the serious risks and harms associated with these medicines, so they may be prescribed and used inappropriately.”

The new information, to be added to an updated boxed warning and to prescribing information for all benzodiazepine medicines, will provide a uniform method of describing the risks of misuse or abuse, as well as risks of addiction and the potential for withdrawal symptoms “consistently across all the medicines in the class,” according to FDA…