Zelnorm (tegaserod maleate) Information

ROCKVILLE, Md., 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.

Background

On March 30, 2007, the FDA asked Novartis to suspend its U.S. marketing and sales because a safety analysis found a higher chance of heart attack, stroke, and unstable angina (heart/chest pain) in patients treated with Zelnorm compared with treatment with an inactive substance (placebo).

On July 27, 2007, the FDA announced that it was permitting the restricted use of Zelnorm (tegaserod maleate) under a treatment investigational new drug (IND).

Questions and Answers About the Voluntary Discontinuation of Zelnorm’s (tegaserod maleate) Treatment Investigational New Drug (IND)

 

1. What is Zelnorm?

Zelnorm is a medicine used for the short-term treatment of women who have irritable bowel syndrome (IBS) with constipation (hard stools or difficulty passing stools) as their main bowel problem. Zelnorm was approved July 24, 2002 for the treatment of IBS-C and August 21, 2004 for the treatment of chronic idiopathic constipation (CIC)

On March 30, 2007, Novartis suspended its U.S. marketing and sales at the request of  FDA, because a safety analysis found a higher chance of heart attack, stroke, and unstable angina (heart/chest pain) in patients treated with Zelnorm compared with treatment with an inactive substance (placebo). 

On July 27, 2007, the FDA announced the restricted use of Zelnorm (tegaserod maleate) under a treatment investigational new drug (IND).

2. What new information is FDA sharing today about Zelnorm?

Novartis Pharmaceuticals of East Hanover, N.J., the manufacturer of Zelnorm, has informed the U.S. Food and Drug Administration of its intent to no longer make Zelnorm available under a treatment IND (investigational new drug) protocol. However Novartis will continue to make Zelnorm available for patients under an emergency IND.

3. Why is the Zelnorm treatment IND protocol being stopped?

This was a voluntary decision made by Novartis. This was not in response to any FDA regulatory action.  

4. How will Novartis notify providers and patients?

On April 2, 2008, Novartis will notify healthcare providers treating patients under the treatment IND protocol in writing.

5. How will this impact patients receiving Zelnorm under the treatment IND?

Novartis will continue to supply Zelnorm only for emergency use.  An emergency situation is defined as one that is immediately life-threatening or serious enough to
qualify for hospitalization.

6. What other treatment options are available for patients?

There is no other FDA approved drug to treat IBS-C. There are options available that could relieve some of the symptoms of IBS.

7. How will FDA aid patients during this process?

The FDA can authorize use of Zelnorm for emergency uses only.  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.

8. What does FDA recommend patients do?

Patients should speak with their physicians to learn whether they might qualify for treatment with Zelnorm for emergency use.

9. Would FDA deny authorization for treatment with Zelnorm?

FDA may deny authorization, even in life-threatening situations, if available evidence fails to provide 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, anxiety, obesity, depression, and suicidal ideation.

Posted: April 2008


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