At the end of March 2019, the U.S Food and Drug Administration (FDA) approved the reintroduction of tegaserod (brand name Zelnorm), an oral medication for irritable bowel syndrome with constipation (IBS-C) to the U.S., only for women without risk factors for or history of cardiovascular conditions.
Tegaserod, a selective serotonin type 4 receptor partial agonist was available in the United States and Canada from 2002-2007, when the FDA and Health Canada, each asked for its withdrawal due to many reports of serious side effects, including unstable angina and strokes. Since then, the FDA has only made Zelnorm available on a rare emergency basis after a physician application for specific individual patients. The current FDA approval is based on an extensive review of 29 clinical trials plus additional outcome data for tegaserod, which found it effective for symptom reduction and safe for a large proportion of potential users. The medication should be available for doctors to prescribe within a few months.
Posted: April 2019