On September 23, 2020, the U.S. Food and Drug Administration (FDA) announced that the Boxed Warning on benzodiazepines must be updated to address the serious risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions. The current prescribing information for benzodiazepines does not provide adequate warnings about these risks. The FDA will also be requiring changes to the Medication Guide and several other sections of benzodiazepine prescribing information.
Before prescribing benzodiazepines, healthcare providers should take actions that include, but are not limited to the following:
- Consider all treatment options and provide information about non-drug alternatives.
- Warn patients and caregivers about the risks associated with benzodiazepine use.
- Limit dosage and duration to the minimum needed to achieve the necessary clinical effect.
- Use caution if patients are already taking opioids or other central nervous system depressants.
- Assess and monitor for abuse, misuse, or addiction.
- When dose reduction or discontinuation is clinically appropriate, gradually taper the dosage to reduce the risk of withdrawal symptoms.