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June 22, 2022June 30, 2022 – Drug manufacturer Alfasigma has withdrawn Zelnorm® (tegaserod) from the U.S. market. According to the company, the withdrawal is the result of a business decision and not based on the safety or efficacy of the drug.
- Zelnorm received FDA approval in 2002 to treat irritable bowel syndrome with constipation (IBS- C) in female patients. It was withdrawn from the market in 2007 due to concerns over increased risk of heart attack, stroke, and unstable angina.
- In 2019, Zelnorm was reintroduced to the U.S. marketing as a treatment for IBS-C in female patients under 65 years age.
- Zelnorm will remain available to patients until the current supply is exhausted. Several potential treatment alternatives are currently available in the U.S.