October 9, 2020

FDA Requires Boxed Warning Update for Benzodiazepines

The FDA published a new drug safety communication, requiring a Boxed Warning update across all benzodiazepine medications to better address serious risks associated with the drug.

Benzodiazepines are widely used to treat many conditions, including anxiety, insomnia, and seizures. These conditions are regularly seen in workers’ comp patients, and therefore injured populations are impacted by this update.

According to the FDA, even when taken at recommended dosages, benzodiazepine use can lead to misuse, abuse, and addiction. Abuse and misuse can result in overdose or death, especially when benzodiazepines are combined with other medications, such as opioid pain relievers – which are also common in workers’ comp – or other substances including 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.

The FDA believes current prescribing information for benzodiazepines did not provide adequate warnings about the serious risks and harms associated with these drugs, as well as the risks of combining benzodiazepines with other medications and substances.

These risks will now be included in Boxed Warnings across all benzodiazepine products, as well as within patient Medication Guides. Other changes are also being required to several sections of the prescribing information, including to the Warnings and Precautions, Drug Abuse and Dependence, and Patient Counseling Information sections.

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