On September 23, 2020, FDA issued an update to the benzodiazepine drug class boxed warning to emphasize the serious risk of addiction, abuse, and withdrawal reactions. Healthcare providers prescribe benzodiazepines to treat various conditions like anxiety, insomnia, and seizures. Common medications under the benzodiazepine drug class include alprazolam (Xanax), clonazepam (Klonopin), and lorazepam (Ativan). The update is based on post-marketing data analysis over several years. These data included a variety of factors including the following examples. In 2018, 50% of patients were receiving benzodiazepine prescriptions for two months or longer. In 2016, nonmedical use of benzodiazepines accounted for 167,845 emergency department (ED) visits compared to 129,863 for prescription opioids. Over half of benzodiazepine deaths from 2013 -2017 also involved prescription opioids.
Healthcare providers can do some of the following to reduce the potential of abuse, addiction, or withdrawal with benzodiazepines. Use the smallest effective dose. The risk for overdose and death increases with combination of opioids, alcohol, or illicit drugs. Screen patients for risk of addiction, abuse, or misuse before starting a benzodiazepine and monitor throughout the treatment course. If substance abuse disorder is suspected, refer the patient for treatment. Physical dependence can occur after consistent use for several days. Taper benzodiazepines to reduce the risk of withdrawal reactions. Withdrawal reactions can be life-threatening due to risk of seizures.
Patients should call 911 or go to the ED if they are having trouble breathing. Take benzodiazepines as prescribed, do not stop taking them abruptly as this may increase the risk for withdrawal symptoms. Common withdrawal symptoms include anxiety, blurry vision, memory problems, trouble sleeping, muscle pain, irritability, and tremors. Patients should contact their healthcare providers if withdrawal symptoms occur.
Boxed warning updates also apply to prescribing information and patient medication guides. The goal is to make healthcare providers, patients, and caregivers more aware of the serious risks of using benzodiazepines.
FDA requires the distribution of Medication Guides for drugs determined to be a serious and significant public health concern. Distribution requirements and exceptions (eg, certain inpatient care situations) for Medication Guides are addressed in an FDA Guidance Document: www.fda.gov/Drugs/DrugSafety/ucm085729.htm.
Additional information on the boxed warning update and adverse event reporting is available below.
Copyright 2020, Drug Information Service, University of Utah, Salt Lake City, UT.