On March 30, 2007, Novartis has announced that it has agreed with an FDA request to suspend the marketing of Zelnorm which is a popular drug prescribed for Irritable Bowel Syndrome.
A recent analysis of clinical trial data identified a small imbalance that was statistically significant in the number of cardiovascular ischemic events in patients taking Zelnorm. These events included heart attack, stroke and unstable angina. They occurred primarily in patients who had pre-existing cardiovascular disease and/or cardiovascular risk factors. There is no demonstrated causal relationship between Zelnorm and these events.
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