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Zelnorm

Zelnorm restricted access program terminated

(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

Physicians with patients who may qualify for treatment with Zelnorm for emergency use may contact FDA’s Division for Drug Information about the emergency IND process at druginfo@fda.hhs.gov.

 

FDA News

    The FDA has posted news about the Zelnorm restricted treatment use protocol here.

Zelnorm sales and marketing discontinued

(March 30 , 2007) Novartis Pharmaceuticals has voluntarily discontinued U.S. and Canadian marketing and sales of their drug tegaserod maleate (Zelnorm). Zelnorm is a treatment for women who have irritable bowel syndrome with constipation as their main bowel problem, and for patients younger than 65 years with chronic constipation.  The action was taken in response to a requests by the U.S. Food and Drug Administration (FDA) and Health Canada. The request from FDA and Health Canada is based on new information regarding increased risk of serious cardiovascular adverse events.

We have been advised by Novartis that they are working to identify ways to determine what people are at risk for these adverse events, and working with FDA to find ways to bring back the drug for patients who need it most.

If you are now taking Zelnorm, FDA advises you to call your doctor and discuss appropriate alternative treatments.

You can also find out more from Novartis by calling 1-888-669-6682; from the FDA, Drug Information, at 1-888-463-6332; or from or Health Canada at 1-613-954-6522.

Information is available online from Novartis.

You may also go to this FDA web page or Health Canada web page for information.

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Last modified on April 3, 2010 at 01:11:06 PM