FDA issues label change for all benzodiazepines to help improve their safe use

September 29, 2020 · Clinical Team

The U.S. Food and Drug Administration (FDA) has issued a labeling change requiring the Boxed Warning and other precautions included in prescribing information to be updated for all benzodiazepines.

Although these medications are FDA-approved to treat a variety of conditions (e.g., anxiety disorder, insomnia and seizures), they are often misused, whether intentional or unintentional, both alone and in combination with alcohol, opioid analgesics and illicit substances.

The September 23, 2020 FDA communication requires new warnings about the increased risk of abuse, misuse, addiction, physical dependence and withdrawal reactions for all benzodiazepines. Additionally, information will be added to patient Medication Guides to help educate patients and caregivers about these additional risks.

Impact on workers’ compensation and auto no-fault

Medical treatment guidelines and state-specific regulations, typically, do not recommend long-term use of benzodiazepines or concurrent use with opioid analgesics, regardless of their reason for treatment. For this reason, Optum Workers’ Comp and Auto No-fault only allows benzodiazepines on some of our standard formularies with maximum fill limits when warranted.

When reviewing claims where a benzodiazepine is prescribed, claims professionals should determine if there is a plan to limit benzodiazepine use to a short-term basis. If there are plans to stop treatment, benzodiazepines should be gradually discontinued to avoid withdrawal symptoms, including seizures that could be life-threatening.

General recommendations for use

Benzodiazepines, such as alprazolam, clonazepam, and lorazepam, are commonly prescribed alone or in combination with other central nervous system (CNS) medications, including but not limited to antidepressants, opioid analgesics, gabapentinoids, and skeletal muscle relaxants to treat complex claims. The co-prescribing of opioid analgesics with benzodiazepines should be avoided whenever possible and dosages and durations of use should be limited to the minimum required.

If your claimants have questions related to this warning, please encourage them to discuss their concerns with their healthcare professional(s).

To learn more about this FDA warning, click here.

If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.

Source:

U.S. Food and Drug Administration. FDA Drug Safety Communication. FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class. September 23, 2020. Available at: https://www.fda.gov/.