Novartis pulled Zelnorm off the market in March 2007.
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.”
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.
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.
This put the risk of Zelnorm heart attacks and strokes at eight times that of the placebo group.
