New FDA Warning on Benzodiazepines: What Does It Really Mean?

Updated: Mar 22, 2023

This past Wednesday, September 23, 2020, the U.S. Food and Drug Administration (FDA) issued a new boxed warning for benzodiazepines, the most common class of anti-anxiety medication which includes Xanax, Klonopin, Ativan, Valium, and many others. This announcement warns of serious risks of abuse, addiction, physical dependence, and withdrawal reactions from these drugs. It’s a significant announcement, and one that’s left the benzo community abuzz.

But what does this communication really mean? What is an FDA boxed warning? What triggered this warning? Does this warning really change anything? I spent that past couple of days reviewing the FDA communication and some of the media coverage around it, and I might have found a few answers. And of course, a few opinions. I hope it helps. D 😊

Video ID: EA021

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Chapters

00:00 Teaser 01:01 Introduction 03:30 What Is a Boxed Warning? 03:45 What Does It Mean? 04:30 What Triggered this Announcement? 06:00 Do They Consider Them Addictive? 07:00 Is It the First Boxed Warning? 07:28 Does It Include Z-drugs? 08:17 Other Governments and Benzos? 09:00 Other U.S. Government Warnings? 11:38 Why the Addiction Language? 13:00 What If I’m Taking a Benzo? 14:18 My Doctor Doesn’t Believe Me 15:18 But I’ve Never Taken a Benzo 16:30 Closing Thoughts

References

Ashton, C. Heather. “The Bridge Project, Bradford: Speech by Professor C Heather Ashton, DM FRCP: Annual Meeting, December 2011.” Benzo.org.uk. Accessed January 27, 2017. https://www.benzo.org.uk/chabradford.htm.
Ashton, C. Heather. Benzodiazepines: How They Work and How to Withdraw (aka The Ashton Manual). 2002. Accessed April 13, 2016. http://www.benzo.org.uk/manual.
Foster, D E. Benzo Free: The World of Anti-Anxiety Drugs and the Reality of Withdrawal. Erie, Colorado: Denim Mountain Press, 2018. https://easinganxiety.com/book.
Fox, Jeremy C. “When withdrawal is the hardest part.” The Boston Globe. September 8, 2014. https://www.bostonglobe.com/lifestyle/health-wellness/2014/09/07/when-withdrawal-hardest-part/nyWtjexiyOWSpU1TkloVnK/story.html.
Frances, Allen. “Yes, Benzos Are Bad for You.” Pro Talk: A Rehabs.com Community, June 10, 2016. Accessed October 13, 2016. https://www.rehabs.com/pro-talk-articles/yes-benzos-are-bad-for-you/.
In Pills We Trust. Discovery Channel. December 4-18, 2001. Quoted in “Professor Malcolm H Lader Quotations.” BenzoBuddies. Accessed March 1, 2017. https://www.benzo.org.uk/lader2.htm.
Kaplan, Sheila. “F.D.A. Requires Stronger Warning Label for Xanax and Similar Drugs.” New York Times. September 23, 2020. Accessed September 25, 2020. https://www.nytimes.com/2020/09/23/health/benzodiazepines-fda-warning.html.
Lader, Malcolm. “History of Benzodiazepine Dependence.” Journal of Substance Abuse Treatment 8 (1991):53-59. Accessed March 1, 2017. doi:10.1016/0740-5472(91)90027-8.
Rodriguez, Adrianna. “FDA requires stronger warning label for Xanax, Valium and other similar benzodiazepine drugs.” USA Today. September 24, 2020. Accessed September 25, 2020. https://www.usatoday.com/story/news/health/2020/09/24/fda-requires-stronger-warning-label-xanax-valium-similar-drugs-benzodiazepine/3516126001/.
Salzman, Carl et al. “Benzodiazepine Dependence, Toxicity, and Abuse: A Task Force Report of the American Psychiatric Association.” Washington, D.C.: American Psychiatric Association, 1990.
U.S. Drug Enforcement Agency (DEA). Drug Info: Drug Scheduling. Accessed March 2, 2018. https://www.dea.gov/druginfo/ds.shtml.
U.S. Drug Enforcement Agency (DEA). Office of Diversion Control; Drug & Chemical Evaluation Section: Benzodiazepines (January 2013). Accessed March 6, 2017. https://www.deadiversion.usdoj.gov/drug_chem_info/benzo.pdf.
U.S. Food & Drug Administration (FDA). “A Guide to Drug Safety Terms at FDA.” FDA Consumer Health Information (PDF). Accessed September 26, 2020. https://www.fda.gov/media/74382/download.
U.S. Food & Drug Administration (FDA). “FDA Requires Strong Warnings for Opioid Analgesics, Prescription Opioid Cough Products, and Benzodiazepine Labeling Related to Serious Risks and Death from Combined Use.” FDA News Release (August 31, 2016). Last Updated August 31, 2016. Accessed September 21, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm518697.htm.
U.S. Food & Drug Administration (FDA). ” FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class.” FDA Drug Safety Communication (September 23, 2020). Accessed September 24, 2020. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm518697.htm.
U.S. Food & Drug Administration (FDA). ” FDA Requiring Labeling Changes for Benzodiazepines.” FDA News Release (September 23, 2020). Accessed September 24, 2020. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm518697.htm.

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