FDA Drug Safety to require Box Warning updates for benzodiazepines.

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Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information.

To address the serious risks of abuse, addiction, physical dependence, and withdrawal reactions, on September 23, 2020 FDA required the Boxed Warning be updated for all benzodiazepine medicines. Benzodiazepines are widely used to treat many conditions, including anxiety, insomnia, and seizures. The 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.

Benzodiazepines can be an important treatment option for treating disorders for which these drugs are indicated. However, even when taken at recommended dosages, their use can lead to misuse, abuse, and addiction. Abuse and misuse can result in overdose or death, especially when benzodiazepines are combined with other medicines, such as opioid pain relievers, alcohol, or illicit drugs. Physical dependence can occur when benzodiazepines are taken steadily for several days to weeks, even as prescribed. Stopping them abruptly or reducing the dosage too quickly can result in withdrawal reactions, including seizures, which can be life-threatening.

We required the Boxed Warning, FDA’s most prominent warning, be updated and other information describing the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions be added to the prescribing information for all benzodiazepine medicines. We are also requiring updates to the existing patient Medication Guides to help educate patients and caregivers about these risks.

Other changes are also being required to the Warnings and Precautions, Drug Abuse and Dependence, and Patient Counseling Information sections.

Health care professionals should consider the patient’s condition and other medicines being taken, and assess the risk of abuse, misuse, and addiction when prescribing benzodiazepines. Caution should be taken when prescribing with opioids and other medicines that depress the central nervous system.

We reviewed post-marketing databases, adverse event cases reported to FDA, and the published literature. Our review found that benzodiazepines are widely prescribed and widely abused and misused in the U.S., often for long periods of time. Also, some patients have had serious withdrawal reactions after benzodiazepines were stopped suddenly or the dose was reduced too quickly. Some patients experienced withdrawal symptoms lasting many months.

Side effects involving benzodiazepines should be reported to FDA’s MedWatch program at www.fda.gov/medwatch.

A link to the full communication detailing specific information for health care professionals and the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications. You can reach us at druginfo@fda.hhs.gov and follow us on Twitter @FDA_Drug_Info.

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• Content current as of:

  01/14/2022

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