JAMA. Published online January 8, 2021. doi:10.1001/jama.2020.22106
In September 2020, the US Food and Drug Administration (FDA) announced an anticipated update to the boxed warning on all benzodiazepines to explicitly “address the serious risks of abuse, addiction, physical dependence, and withdrawal reactions” among this class of medications.1 The current boxed warning for benzodiazepines (eg, alprazolam, lorazepam, clonazepam, diazepam) highlights only the risks of coadministration of opioids and benzodiazepines. Benzodiazepines are prescribed for multiple indications, most notably generalized anxiety disorder, panic, social phobia, insomnia, and seizure prophylaxis and rescue.
In addition to the revised boxed warning, the FDA is also modifying the detailed prescribing information. The new prescribing information advises physicians to warn patients of the risks of benzodiazepines; assess patients’ risk of abuse, misuse, and addiction; use caution when coprescribing benzodiazepines with opioids; seek the lowest effective dose for the shortest treatment duration possible and taper off benzodiazepines slowly; consider alternate therapies; and follow up with patients who are prescribed benzodiazepines frequently.1
This increased caution regarding benzodiazepine use is warranted; fewer benzodiazepine prescriptions are needed. However, when considered without an appropriate patient-centered context, this enhanced warning statement might lead to fewer appropriate prescriptions and unintended consequences. This Viewpoint reviews the relative benefits and risks of benzodiazepines, discusses potential consequences of the FDA amendments, and describes a potential approach for the rational prescribing of benzodiazepines.
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