All sales of the irritable bowel syndrome drug Zelnorm (the common name for tegaserod maleate) were suspended on March 30, 2007 by their manufacturer Novartis in accordance with an FDA request. Novartis released the results of 29 clinical studies on Zelnorm earlier this year, which lead the FDA to believe there may be a link between Zelnorm and an increase in heart attack or stroke in patients. The data revealed that 0.11% of tested Zelnorm patients (13/11,614) suffered a heart attack or stroke when compared to 0.01% (1/7,031) who suffered heart attack or stroke when given a placebo. Of the 13 affected Zelnorm patients, one person actually died from the effects. The one affected placebo patient only showed symptoms typical of the beginning of a stroke, which dissipated without complications.
The removal of the dangerous product may prove to have a significant impact on the company Novartis, as estimated sales for 2011 of Zelnorm were as high as $1 billion, with a proven $488 million last year in the U.S. alone. The FDA had initially approved the drug in 2002, and now claims that it may later allow a limited reintroduction of Zelnrom “if a population of patients can be identified in whom the benefits of the drug outweigh the risks.”1 The company Novartis still claims that Zelnorm can still provide significant benefits for those suffering from irritable bowel syndrome.
But do the benefits outweigh the costs? Public Citizen, the consumer advocacy group, advised the FDA in 2001 not to approve the drug because they believed the drug was more dangerous than it was helpful. Of the drug’s approval in 2002, director of Public Citizen’s health research group, Dr. Sidney Wolfe stated, “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.”1
