FDA requires new boxed warning on benzodiazepines

The FDA is requiring an update to the Boxed Warning on all benzodiazepines and new labeling that includes the medications’ risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions.

“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,” FDA said in its Drug Safety Communication.

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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, FDA added.

FDA is also warning that 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,” the agency said.

In 2019, an estimated 92 million benzodiazepine prescriptions were dispensed from U.S. outpatient pharmacies. Alprazolam (Xanax) was the most commonly prescribed in the class at 38%, followed by clonazepam (Klonopin) at 24%, and lorazepam (Ativan) at 20%.

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“We are taking measures and requiring new labeling information to help health care professionals and patients better understand that while benzodiazepines have many treatment benefits, they also carry with them an increased risk of abuse, misuse, addiction and dependence,” said FDA Commissioner Stephen M. Hahn, MD, in a statement.

In addition to requiring an update to the Boxed Warning, the FDA is requiring other changes to the Warnings and Precautions, Drug Abuse and Dependence and Patient Counseling Information sections of the prescribing information for all benzodiazepine products.

The agency is also requiring revisions to the existing patient Medication Guides for these medicines to help educate patients and caregivers about the risks.

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