SPOTLIGHT: FDA allows limited Zelnorm use

The FDA said it will allow the restricted use of Zelnorm under an IND protocol to treat irritable bowel syndrome with constipation and chronic idiopathic constipation in women younger than 55 who meet specific guidelines. In April Novartis withdrew Zelnorm from the market [1] because a safety analysis found a higher chance of heart attack, stroke and unstable angina in patients taking the drug. Regulators decided that the drug should be available to patients with a critical need for it, but it will remain off the market for general use. Release [2]