Is Zelnorm back on the market?
Zelnorm was withdrawn from the U.S. market in 2007. Has it been reintroduced?
Medically reviewed by Drugs.com Last updated on Apr 4, 2019.
Official Answerby Drugs.com
It is expected to become available in the months following the announcement.
- Zelnorm was originally approved by the FDA in 2002 for the treatment of IBS-C in women.
- In March 2007, Zelnorm was voluntarily withdrawn from the U.S. market because a safety analysis found a higher chance of heart attack, stroke, and unstable angina (heart/chest pain) in patients treated with Zelnorm compared with those who were treated with a placebo.
- In July 2007, the FDA announced that it was permitting the restricted use of Zelnorm for certain patients when there was no satisfactory alternative treatment available.
- In March 2019, the FDA approved the reintroduction of Zelnorm for the treatment for Irritable Bowel Syndrome with Constipation (IBS-C) in women under 65. Approval came after a complete safety review by the FDA and the Gastrointestinal Drugs Advisory Committee (GIDAC). The review focused on the evaluation of clinical data from 29 placebo-controlled trials and newly-available sources of treatment outcome data. A positive GIDAC vote and FDA review both supported the reintroduction of Zelnorm for appropriate IBS-C patients.
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