East Hanover, NJ - Novartis, in compliance with an FDA request, has suspended marketing and sales of its irritable bowel/constipation drug Zelnorm (tegaserod maleate), after an analysis of its clinical database pointed to a higher incidence of MI, stroke, and unstable angina among patients taking the drug.
According to a company press release, a statistically nonsignificant trend toward more angina was seen among people taking the drug in the clinical trial that led to the drug's approval in 2002. But in a recent analysis of 18 000 patients in the entire clinical database, adverse cardiovascular events were seen in 13 out of 11 614 patients (0.11%) on Zelnorm, but in only one patient (0.01%) out of 7031 taking placebo, a statistically significant difference.
The FDA plans to call a public hearing and advisory committee meeting to evaluate the risk/benefit profile of Zelnorm; the company, meanwhile, has stopped marketing the product but states in a press release that the 0.11% rate of adverse events is in keeping with the expected rates for such events in the general public. It also noted that no effect of tegaserod maleate on the coronary arteries was seen in preclinical and clinical testing.
Quoted in a company press release as "an independent cardiologist," Dr Jeffrey L Anderson (University of Utah, Salt Lake City) commented, "My review of the data suggested that a causal relationship is unlikely between tegaserod and the rare cardiovascular ischemic events observed in clinical trials. Furthermore, the data did not show any consistent pattern of event type, time to event, or dose relationship in tegaserod-treated patients."
The drug received FDA approval in July 2002 for the short-term treatment of women with constipation associated with irritable bowel syndrome and was later approved for use in both men and women with chronic idiopathic constipation, in August 2004.
Heartwire from Medscape © 2007
Cite this: Marketing of constipation drug Zelnorm suspended; drug linked to slight increase in CV events - Medscape - Mar 30, 2007.