Zelnorm Recall

Zelnorm was recalled following reports of heart attack and stroke. Zelnorm, (or tegaserod maleate) , a prescription drug designed to treat symptoms of irritable bowel syndrome in women as well as chronic constipation, has now been associated with serious side effects, prompting the Food and Drug Administration to issue a recall request to the Swiss pharmaceutical manufacturer Novartis AG. The FDA request followed publication of 29 clinical studies involving over 18,000 patients, of which over 11,000 were treated with Zelnorm. Thirteen patients reportedly experienced serious side effects including stroke and heart attack. Recognizing that the adverse risks were rare, the FDA has indicated that the drug’s benefits no longer outweigh its serious risks. The FDA request to pull this drug, a member of the class of serotonin agonists, was made on March 30, 2007, with the corollary that the product may be reintroduced if further clinical testing concludes that the benefits outweigh risks.

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