Drug Safety Alerts

Benzodiazepine Drug Safety Communication

9/23/2020

On September 23, 2020, the United States Food and Drug Administration (FDA) announced they are requiring the Boxed Warning, FDA’s most prominent warning, be updated by adding other information to the prescribing information for all benzodiazepine medicines. This information will describe the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions consistently across all the medicines in the class. The FDA is 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 several sections of the prescribing information, including to the Warnings and Precautions, Drug Abuse and Dependence, and Patient Counseling Information sections.

Benzodiazepines are a class of medicines approved to treat generalized anxiety disorder, insomnia, seizures, social phobia, and panic disorder.

Patients and health care professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online.

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

The FDA recommends that health care professionals:

• Consider the patient’s condition and the other medicines being taken, and assess the risk of abuse, misuse, and addiction.

• Limit the dosage and duration of each medicine to the minimum needed to achieve the desired clinical effect when prescribing benzodiazepines, alone or in combination with other medicines.

• Use a gradual taper to reduce the dosage or to discontinue benzodiazepines to reduce the risk of acute withdrawal reactions.

• Take precautions when benzodiazepines are used in combination with opioid addiction medications.

The FDA recommends that patients, parents and caregivers:

• Always tell your health care professionals about all the prescription and over-the-counter (OTC) medicines you are taking or any other substances you are using, including alcohol.

• Take benzodiazepines and all medicines exactly as prescribed by your health care professional.

• Discuss a plan for slowly decreasing the dose and frequency of your benzodiazepine(s) with your health care professional.

• Contact your health care professional if you experience withdrawal symptoms or your medical condition worsens.

• Go to an emergency room or call 911 if you have trouble breathing or other serious side effects such as seizures.

CVS Caremark® Response: There have been no recalls of these products associated with this announcement.

For more information about this issue, health care providers may contact the FDA consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov.