FDA Updates Black Box Warning for Benzodiazepines

Meg Seymour, PhD. National Center for Health Research


Benzodiazepines, often called “benzos,” are a type of anti-anxiety medication. The most commonly prescribed benzodiazepines are alprazolam (Xanax), clonazepam (Klonopin), and lorazepam (Ativan).1 A list of benzodiazepines can be found in the following table.2

Taking benzodiazepines each day can lead to a physical dependency. Physical dependence on a drug means your body needs the drug in order to function normally. Someone who has regularly been taking a benzodiazepine for weeks or months may experience withdrawal symptoms if they suddenly stop taking the medication or take a lower dose.1

Withdrawal from benzodiazepines includes symptoms such as anxiety, restlessness, delirium, and seizures, and can happen after taking the drug each day for as little as 3 weeks.3,4 In order to prevent dependence on benzodiazepines, health care providers are advised to limit a prescription to a 1-2 week supply.4

What is the new black box warning? 

In September 2020, the FDA announced that they are updating the “black box warning” for benzodiazepines. A black box warning is FDA’s most serious warning about a drug or medical device. FDA will require Medication Guides and prescribing information for benzodiazepines to warn about the risks of physical dependence, withdrawal reactions, misuse, abuse, and addiction.5 Abuse and misuse of benzodiazepines, such as taking them with alcohol, can lead to life-threatening side effects.2

Benzodiazepines already have a black box warning, which warns that taking benzodiazepines at the same time as opioids can lead to extreme sedation, slow and ineffective breathing, comas, and even death.6 FDA’s 2020 decision keeps this previous warning about combining benzodiazepines with opioids and adds additional warnings about the risks of addiction, as well as dangerous withdrawal symptoms. 

The bottom line

Taking benzodiazepines for more than 3 or 4 weeks can put someone at risk for developing an addiction to them or developing a physical dependence without developing an addiction.7,8 The FDA cautions that although benzodiazepines can be beneficial treatments, stopping them suddenly or reducing the dose too quickly can result in withdrawal symptoms that can be life-threatening. The agency warns patients to talk with their healthcare providers in order to develop a plan for safely and slowly tapering off a benzodiazepine.1

 

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

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References

  1. U.S. Food & Drug Administration. FDA Requiring Labeling Changes for Benzodiazepines. Fda.gov. https://www.fda.gov/news-events/press-announcements/fda-requiring-labeling-changes-benzodiazepines. September 2020. 
  2. U.S. Food & Drug Administration. FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class. FDA.gov. https://www.fda.gov/drugs/drug-safety-and-availability/fda-requiring-boxed-warning-updated-improve-safe-use-benzodiazepine-drug-class. September 2020. 
  3. Osborn C. How Long Does Withdrawal From Benzodiazepines Last?. Verywellmind.com. https://www.verywellmind.com/benzodiazepine-withdrawal-4588452. Updated April 2020. 
  4. Brett J, Murnion B. Management of benzodiazepine misuse and dependence. Australian Prescriber. 2015;38(5):152.
  5. U.S. Food & Drug Administration. FDA Drug Safety Communication. FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class. Includes potential for abuse, addiction, and other serious risks. September 2020. Retrieved from https://www.fda.gov/media/142368/download
  6. U.S. Food & Drug Administration. Safety labeling change notification. 2016. Retrieved from: https://www.fda.gov/media/99689/download
  7. UCLA Jane & Terry Semel Institute for Neuroscience & Human Behavior. Benzodiazepine Addiction. Semel.ucla.edu. https://www.semel.ucla.edu/dual-diagnosis-program/Conditions_Treated/Benzodiazepine_Addictions.
  8. HHS. Opioids: Understanding Addiction Versus Dependence. Hhs.edu. https://www.hss.edu/conditions_understanding-addiction-versus-dependence.asp. 2018.