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Market Withdrawal of Zelnorm

Posted on April 29, 2008

Novartis Pharmaceuticals has agreed to stop selling Zelnorm because of safety concerns. Zelnorm (tegaserod maleate) had been approved to treat certain patients with irritable bowel syndrome and chronic constipation.

Zelnorm was taken off the market because a new analysis of 29 studies showed that taking this drug increased the risk of serious cardiovascular adverse events. Because of this, FDA believes that the benefits of the drug no longer outweigh the risks.

Patients being treated with Zelnorm should contact their doctors to discuss alternative treatments.

Prescribers should work with their patients to find other appropriate therapies. There may be some patients, however, with no other treatment options where the benefits of Zelnorm outweigh the risks. These patients may continue to receive Zelnorm if necessary through a special program that FDA has established with Novartis. Physicians can apply to the FDA for permission to prescribe Zelnorm for a patient through what's called an "Emergency IND."

Additional Information:

FDA MedWatch Safety Alert. Zelnorm (tegaserod maleate). March 30, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Zelnorm

FDA Center for Drug Evaluation and Research. Questions and Answers on Zelnorm (tegaserod maleate). March 30, 2007.
http://www.fda.gov/cder/drug/infopage/zelnorm/zelnorm_QA_2007.htm

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