2000—Two digestive-system drugs that manipulate serotonin, Propulsid and Lotronex, are taken off the market. The former is found to cause heart problems, and the latter can cause life-threatening constipation.
July 2002—The FDA approves Novartis’ Zelnorm for the treatment of irritable bowel syndrome (IBD) in women. It is intended for short-term treatment.
April 28, 2004—The FDA informs doctors about new labeling to warn of the risk of Zelnorm side effects. The specific revisions include warnings about diarrhea and ischemic colitis. According to the FDA, several Zelnorm deaths were reported among patients with these conditions.
August 2004—The FDA permits the use of Zelnorm for men and women with chronic constipation, although all previous clinical studies have been done on female patients.
April 29, 2005—The FDA and Novartis again change Zelnorm’s label, referring to consequences of diarrhea that occurred both during clinical trials and during marketed use, some of which required hospitalization.
2005—More than 2 million prescriptions written for Zelnorm in the U.S.
Late 2006—At the request of Swiss government officials, Novartis performs a routine safety review of Zelnorm. The company’s analysis of its clinical trial data indicates that people on the drug were eight times more likely to suffer Zelnorm heart attacks or strokes compared with a placebo group.
February 2007—Novartis reports its findings on the side effects of Zelnorm to the FDA
March 28, 2007—After an investigation, the FDA asks Novartis to pull Zelnorm from the market due to the risk of side effects.
March 30, 2007—Novartis complies with the FDA’s request, halting all marketing and sales of Zelnorm. According to the FDA, Novartis will issue a Zelnorm recall in the future.