FDA Requires Stronger Warnings for Benzodiazepines   

FDA, Medicare Set-Aside Blog on October 22, 2020
Posted by Leah King, PharmD, JD, Independent Pharmacy Consultant

On September 23, 2020, the FDA Drug Safety Commission announced that manufacturers of benzodiazepines will be required to update the boxed warning within the prescribing information for these products. Benzodiazepines, a group of medications that includes Ativan (lorazepam), Xanax (alprazolam) and others, are commonly used to treat anxiety disorders, panic disorder, insomnia, certain types of seizures, and phobias. Benzodiazepines exert their action through a sedative effect. By increasing the activity of a naturally occurring chemical within the brain, benzodiazepines are able to slow down certain functions within the body.

Benzodiazepines are classified as Schedule IV controlled substances, as they carry a low potential for abuse and low risk of dependence. However, risks do exist, as well as possible side effects of drowsiness, confusion, dizziness, impaired coordination, headache, and feelings of depression. When benzodiazepines are prescribed in isolation, the Schedule IV classification is likely justified. In clinical practice, however, we know that benzodiazepines may be prescribed in combination with other drugs that depress the central nervous system, such as opioids, risking more pronounced central nervous system depression and thus the risk for respiratory depression and death. (This also applies to the combination of benzodiazepines and alcohol.) Addressing this patient safety perspective, in 2019 CMS issued an educational piece regarding the use of benzodiazepines and opioids in combination. We wrote about this on our blog. If you missed it, you can read it here.

In its announcement on September 23rd, the FDA indicated that it has been aware of several concerning trends with benzodiazepines over the past few years. Through its review of available information sources, including published medical literature, adverse event reports, and post- marketing databases, the FDA notes that benzodiazepines are often used for long periods of time; are sometimes used and misused in potentially dangerous combinations with other drugs; and can lead to prolonged withdrawal symptoms if discontinued abruptly.

In the FDA’s estimation, the current prescribing information for benzodiazepines does not adequately convey the serious risks and potential harm associated with these drugs, which are necessary to ensure safe and appropriate use. For this reason, the FDA will require manufacturers of benzodiazepines to update the boxed warning within the prescribing information to describe the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions consistently across all medications in the benzodiazepine category. The FDA will also require updates to Medication Guides for these drugs in order to help educate patients and caregivers about the risks associated with the use of benzodiazepines. Other changes are also being mandated for the following sections within the prescribing information for these drugs: Warnings and Precautions, Drug Abuse and Dependence, and Patient Counseling Information.

For the past few years, we have detailed the efforts of the federal government to curtail the disturbing trend of drug abuse and addiction in our nation. This is yet another example of ways in which federal agencies have taken steps to educate prescribers, patients and caregivers about the dangers associated with benzodiazepines. As you may recall, Medicare Part D updated its policy to provide coverage of benzodiazepines for Medicare beneficiaries starting in January 2013.  We will continue to monitor FDA announcements and post updates on our blog. You can read the full text of the FDA announcement here.