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Voluntary Recall Of Zelnorm Issued After Prompt By FDA

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The sale of Zelnorm, (tegaserod maleate) approved in 2002 for treatment of irritable bowel syndrome with constipation, has recently been suspended by its manufacturer, Novartis, after the drug has been linked to a significant number of cardiovascular risks. This decision was made after the United State Food and Drug Administration found the drug can lead to increased occurrences of heart attack, stroke and serious chest pains. Doctor’s with patients taking Zelnorm are being asked by the FDA to work with their patients to find other suitable replacement medications and therapies.

Earlier this year, Novartis gave the FDA the results of new analyses of 29 clinical studies of Zelnorm for treatment of a variety of gastrointestinal tract conditions. The analyses showed 13 of 11,614 patients given Zelnorm had serious and life-threatening cardiovascular side effects, while just one of the 7,031 patients given dummy pills did, the FDA and Novartis said in separate statements.

The FDA has told Novartis it would consider allowing a limited reintroduction of Zelnorm “if a population of patients can be identified in whom the benefits of the drug outweigh the risks,” the agency said.