Constipation Medication Zelnorm Linked To Apparent Increased Risk Of Heart Attacks And Strokes

Novartis Suspends Sales After FDA Determines That Risks Of Serious Side Effects Outweigh Benefits Of Zelnorm

(Posted by Tom Lamb at DrugInjuryWatch.com)

On March 30, 2007 the FDA announced that Novartis Pharmaceuticals Corporation had suspended the marketing and sales of Zelnorm (tegaserod), a widely prescribed medication for irritable bowel syndrome (IBS) and constipation, due to an apparent increased risk of heart attacks and strokes in patients using Zelnorm.

According to a March 30, 2007 FDA News release entitled "FDA Announces Discontinued Marketing of GI Drug, Zelnorm, for Safety Reasons":

Zelnorm was approved for short-term treatment of women with irritable bowel syndrome whose primary symptom is constipation and for men and women younger than 65 with chronic constipation.

An analysis of 29 placebo-controlled clinical trials comprising over 18,000 patients conducted by Novartis found 0.1% of patients taking Zelnorm showed evidence of a serious cardiovascular event, compared with 0.01% taking a placebo. The FDA concluded that, for most patients, the benefits of Zelnorm no longer outweigh the risks. The agency is working with the manufacturer to keep the drug available for those who have no other treatment options.

A time line of the events leading up to Novartis' withdrawal of Zelnorm from the U.S. market is outlined in a March 31, 2007 New York Times article by Gardiner Harris:

The worries about Zelnorm began with a routine safety review last year by drug officials in Switzerland. To prepare, Novartis scientists gathered data from all 29 of their Zelnorm studies and looked for patterns. By January, they had found the difference in heart problems.

Thirteen cases of heart problems in more than 11,000 patients is about what one might find in a normal population, said Dr. Stephen Cunningham, head of clinical development and medical affairs in the United States at Novartis.

The company reported its finding to the drug agency on Feb. 22. The agency mobilized a team of reviewers.

The team met with Novartis officials on March 15 to ask questions. On Thursday, the F.D.A. notified the company that it had decided that Zelnorm should be withdrawn. On Friday the company complied.

Zelnorm was approved by the FDA in July 2002 for short-term treatment of women with irritable bowel syndrome whose primary symptom is constipation and approved in August 2004 for men and women younger than 65 with chronic constipation.

As for how often Zelnorm was prescribed in the U.S., according to a March 30, 2007 Reuters article:

Zelnorm was Novartis's 12th-biggest selling drug in 2006, with global turnover growing 30 percent to $561 million, of which $488 million was generated in the United States.

About 500,000 U.S. patients are taking Zelnorm, Novartis spokeswoman Anna Frable said.

The FDA has released a Public Health Advisory about Zelnorm intended to give doctors and patients further information about why Zelnorm was taken off the market.