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Gastrointestinal medication Zelnorm® (tegaserod) withdrawn from the market
Effective June 30, 2022, Zelnorm 6 mg tablet will no longer be produced and marketed in the United States, as announced by its manufacturer, Alfasigma USA, Inc. Zelnorm is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in adult women under the age of 65. The company stated the decision to no longer make Zelnorm was due to a business decision and was not the result of issues related to safety, quality, efficacy or an imposed recall.
Impact on workers’ compensation and auto no-fault
Although IBS-C is not typically related to a workers’ compensation or auto injury, injured persons should contact their prescriber or health care provider if they have any questions regarding their Zelnorm therapy. Examples of other gastrointestinal medications indicated for the treatment of IBS-C include linaclotide (Linzess®), lubiprostone (Amitiza®), and plecanatide (Trulance®).
Upon review of our transactional data, there was no utilization for Zelnorm in our book of business. Since Zelnorm may still be dispensed as long as pharmacies have adequate quantities available to them, we will not make any changes to our standard formularies at this time. In general, medications used to treat IBS-C are considered non-formulary (e.g., excluded or prior authorization) on our standard formularies.
For more information on this market withdrawal, click here.
If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.
- PRNewswire [press release]. Zelnorm® (tegaserod) Notice of Withdrawal from Market. June 30, 2022. Available at: https://www.prnewswire.com/news-releases/zelnorm-tegaserod-notice-of-withdrawal-from-market-301578099.html.
- Zelnorm (tegaserod) Notice of Withdrawal from Market Frequently Asked Questions. Alfasigma USA. Available at: https://www.myzelnorm.com/assets/pdfs/Zelnorm%20FAQS.pdf. Accessed on July 5, 2022.
- GI & Hepatology News from MDedge. American Gastroenterological Association (AGA) Clinical Practice Guidelines: Pharmacologic treatment of Irritable Bowel Syndrome (IBS). June 22, 2022. Available at: https://www.mdedge.com/gihepnews/article/255665/gastroenterology/aga-clinical-practice-guidelines-pharmacologic-treatment. Accessed on July 5, 2022.