In March 2007, the FDA asked Novartis Pharmaceuticals to withdraw its irritable bowel syndrome drug Zelnorm (tegaserod maleate) from the market in the U.S.

In post-marketing tests, disturbing results were found which indicated increased cardiovascular Zelnorm side effects among patients. Data from 29 clinical studies with more than 18,000 patients demonstrated Zelnorm heart attacks or other cardiovascular side effects 13 of 11,614 patients taking Zelnorm, compared with just 1 of 7,031 patients who got placebos.

This put the risk of Zelnorm heart attacks and strokes at eight times that of the placebo group. [Zelnorm statistics]

Zelnorm was approved in 2002 to treat cases of irritable bowel syndrome, abdominal discomfort, bloating and constipation among women.


Early opposition from Public Citizen
More than 2 million prescriptions were written for Zelnorm in 2005 alone, making it one of the 200 most popular drugs in the U.S. Following reports about the studies of the cardiovascular side effects of Zelnorm, the consumer advocacy group Public Citizen urged the FDA in 2001 not to approve the drug.

Speaking about the risk of Zelnorm side effects, Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, “Once again, the FDA has approved a drug with marginal effectiveness in the face of serious questions about its safety—putting at risk the millions of people who have already used it.” [More expert testimony]

Although Novartis tried to downplay the severity of these Zelnorm side effects, the FDA asked the company to pull the drug from the market on March 28, 2007, and it agreed to do so two days later. The FDA has announced that Novartis is planning to issue a Zelnorm recall, although no date for this has been announced.



Risks outweigh benefits
The head of the FDA’s Office of New Drugs, Dr. John Jenkins, indicated that the drug’s risks had come to outweigh its benefits. According to data from the FDA, serious digestive conditions have led to several Zelnorm deaths in patients.

If you or a loved one have been injured by using Zelnorm, consult with your doctor. If you are considering filing a Zelnorm lawsuit, contact the attorneys of Hissey Kientz at (866) 275-4454 to discuss your legal options. Or you may fill out a free online evaluation form (top right of this page).