Zelnorm Recall Requested by FDA due to Side Effects Including Serious Cardiovascular Problems

FDA requested Zelnorm recall after the drug has been linked to serious side effects including increased risks of stroke and heart attack. Studies show that 13 out of 11,614 patients given Zelnorm suffered serious cardiovascular side effects.

WHITE OAK, Maryland, July 27, 2007 - Novartis, a Swiss pharmaceutical company, has recently announced that it will cease marketing its anti-constipation prescription drug, tegaserod maleate, which is sold under the brand name Zelnorm. Used to treat women who suffer from constipation and irritable bowl syndrome and for patients, under sixty-five, with chronic constipation, Zelnorm has been linked to some side effects including increased risks of stroke and heart attack. According to the consumer advocacy group, Public Citizen, "There were 2.13 million prescriptions issued for Zelnorm in 2005 alone, making it one of the top 200 drugs in the country."

In clinical studies that tested the effectiveness of Zelnorm to treat a number of gastrointestinal ailments, it was found that 13 of 11,614 patients administered Zelnorm were stricken with potentially deadly cardiovascular side effects.

While the Food and Drug Administration (FDA) requested a Zelnorm recall, to pull this potentially harmful drug from the market, it has stated that it will consider allowing Novartis to sell the anti-constipation drug, "if a population of patients can be identified in whom the benefits of the drug outweigh the risks."

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