IBS Drug Zelnorm Withdrawn from Market

Novartis Withdraws Zelnorm From Market Voluntarily After FDA Request in March 2007

Zelnorm drug maker Novartis issued a Dear Doctor Letter, as well as a press release on March 30, 2007, announcing compliance with the FDA's request to withdraw IBS drug Zelnorm from the market.

Zelnorm, a serotonin agonist generically known as tegaserod, was prescribed to patients with severe constipation from irritable bowel syndrome (IBS). In a recent analysis of clinical trials, Zelnorm was found to be associated with cardiovascular events such as heart attack and stroke, prompting the FDA to decide that the risk-versus-benefit profile for Zelnorm was no longer favorable. In turn, the FDA asked Novartis to recall Zelnorm.

Concerns about cardiovascular side effects related to Zelnorm began with a safety review in Switzerland in 2006. Data from 29 Zelnorm studies was analyzed and adverse side effects, including heart attacks and strokes, associated with the use of Zelnorm were found and reported to the FDA.

Read more on our Zelnorm Information Page >>