Pharmaceutical company Novartis has halted sales of Zelnorm. The drug is used to treat irritable bowel syndrome and constipation. The FDA requested that the drug be withdrawn from the market after trial results showed an increase in ischemic events, including angina and strokes, in patients taking Zelnorm, compared with a placebo group. Novartis does not believe that the trials demonstrate a causal link between the drug and the ischemic events. Zelnorm is the only drug approved by the FDA to treat irritable bowel syndrome with predominant constipation. The FDA is working with Novartis on establishing an program where patients who are using the drug can have access to it under an investigational new drug application. Further, if Novartis can identify a patient population where the benefits of using Zelnorm will outweigh the risks, the FDA will consider a limited reintroduction of the drug at a later date.
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