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.

Zelnorm available to U.S. patients under restricted access program

(July 27, 2007) The U.S. Food and Drug Administration (FDA) has approved a protocol that allows limited access to the drug Zelnorm for the treatment of chronic idiopathic constipation, or of IBS where constipation is the predominant bowel symptom. Access will be restricted to women under the age of 55 who meet special enrollment criteria administered through their doctor. Women interested in obtaining Zelnorm are encouraged to contact their doctor. We have posted a summary of the protocol [removed]. 

News from Novartis

(July 27, 2007) In cooperation with the US Food and Drug Administration (FDA), Novartis has established a restricted access program for Zelnorm® (tegaserod maleate) so that patients in need of this medicine can be considered for treatment.

The program, called a treatment IND, is designed to help women in the US under 55 years of age who suffer from irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC), and for whom no other treatment has provided satisfactory relief and/or patients who had satisfactory improvement of their symptoms with prior Zelnorm treatment for IBS-C or CIC. Novartis and the FDA are moving forward with this program because of requests from physicians and patients following the marketing suspension of Zelnorm in March 2007.

Treatment INDs are generally used to allow restricted access to medications for patients in need if no comparable alternative drug or therapy is available to treat the disease. Patients given access through a treatment IND must meet specific FDA-approved criteria for enrollment.

Through the program, appropriate female patients with IBS-C or CIC who are assessed by their physicians as being in critical need can have access to Zelnorm for relief of the often painful and disruptive symptoms associated with these conditions. The program protocol and consent materials are designed to ensure that patients and physicians are fully informed of the potential risks and benefits of Zelnorm.

To be considered for access to Zelnorm through the treatment IND, patients must have IBS-C or CIC and meet the specific criteria in the treatment IND protocol. To become part of the treatment IND, patients should contact their physicians to inquire about the protocol and evaluate if they meet the criteria. For further details of the program’s protocol, physicians can call 866-248-1348 or 888-669-6682 or go to www.zelnorm.com.

For patients who do not meet the criteria of the treatment IND but have an urgent need for Zelnorm based on a life-threatening or severely debilitating condition, there may be an alternative option available through the FDA. Physicians may inquire about this potential access option by contacting Novartis at (888-NOW-NOVA) or the FDA CDER Division of Drug Information at 301-827-4570 or www.fda.gov/cder.

Novartis suspended US marketing and sales of Zelnorm as a result of an FDA request in order to permit further discussion of its benefit/risk profile. This decision was based on a review of a new retrospective analysis of pooled clinical trial data which showed that the incidence of cardiovascular ischemic events was higher in patients taking Zelnorm than in those taking placebo. However, no causal relationship between Zelnorm and cardiovascular ischemic events has been demonstrated.

Novartis has extensively studied Zelnorm and believes that this medicine provides important benefits for appropriate patients. Novartis is in discussions with the FDA to better understand the findings and to determine appropriate next steps. 

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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.