April 1, 2008Further restrictions placed on use of Zelnorm
The Food and Drug Administration and the manufacturer of Zelnorm have placed further restrictions on the types of patients who can be treated with the irritable bowel syndrome (IBS) medication. The new restrictions come more than one year after Zelnorm was recalled in the U.S. after evidence suggested it could cause an increased risk of heart attack or stroke.According to the new guidelines issued by Novartis Pharmaceuticals, Zelnorm will only be made available to patients whose IBS symptoms are life-threatening and require hospitalization. Prior to the change, Zelnorm had been made available on a trial basis to younger women with IBS and constipation.
The FDA has said that it may also restrict the use of the drug for patients with a previous history of heart attack or stroke, or who currently experience high blood pressure, diabetes, obesity or unstable angina, even in life-threatening circumstances.