Withdrawal From Market
On March 30, 2007, the U.S. Food and Drug Administration requested that Novartis withdraw Zelnorm from shelves. The FDA alleges a relationship between prescriptions of the drug and increased risks of heart attack or stroke. An analysis of data collected on over 18,000 patients demonstrated adverse cardiovascular events in 13 of 11,614 patients treated with Zelnorm (a rate of 0.11%) as compared with 1 of 7,031 patients treated with placebo (a rate of 0.01%). Novartis alleges all of the affected patients had preexisting cardiovascular disease or risk factors for such, and further alleges that no causal relationship between tegaserod use and cardiovascular events has been demonstrated. On the same day as the FDA announcement, Novartis Pharmaceuticals Canada announced that it was suspending marketing and sales of the drug in Canada in response to a request from Health Canada. Some manufacturers in India, such as Cipla and Torrent Pharmaceuticals Ltd., seem to still have generic tegaserod available in their listings and some online merchants may be selling it, despite the drug being banned in India. In a large cohort study based on a US health insurance database, no increase in the risk of cardiovascular events were found under tegaserod treatment.
Read more about this topic: Tegaserod
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