April 2, 2008-Novartis, the manufacturer of Zelnorm, has notified the FDA that they will no longer provide Zelnorm (tegaserod maleate) under a treatment investigational new drug application (T-IND) protocol to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55.
Novartis has agreed to continue to supply Zelnorm for use in emergency situations. Requests for Zelnorm for this purpose may be made to the FDA which in turn authorizes shipment of the drug by the manufacturer.
An emergency situation is defined as one that is immediately life-threatening or serious enough to qualify for hospitalization. FDA may deny authorization, even in life-threatening situations, if available evidence fails to provide a reasonable basis for concluding that Zelnorm may be effective for the intended use, or if exposure to Zelnorm would pose an unreasonable or a significant additional risk to patients. The following conditions are cause for denial of authorization:
prior history of heart attack or stroke
unstable angina
hypertension
hyperlipidemia
diabetes
age greater than 55 years
smoking
obesity
depression
anxiety
suicidal ideation
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