[Jeffrey Roberts]

http://www.fda.gov/c...orm/default.htm

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) (4/2/2008)

[Jeffrey Roberts]

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http://www.reuters.com/article/rbssHealthc...235169320080402

Novartis further curbs Zelnorm use in U.S.

Wed Apr 2, 2008 5:24pm EDT

By Susan Heavey

WASHINGTON, April 2 (Reuters) - Novartis (NOVN.VX: Quote, Profile, Research)(NVS.N: Quote, Profile, Research) will further restrict access to its irritable bowel syndrome drug Zelnorm, reserving it for the sickest patients, the company and U.S. health regulators said on Wednesday.

Concerns about a possible link to heart attacks and strokes led the Swiss drugmaker to make a deal last year with the U.S. Food and Drug Administration to provide the drug for a limited number of patients under a special FDA-supervised program.

...

Patient advocate Jeffrey Roberts said the move further burdens patients and doctors who are seeking relief.

He said most Zelnorm patients saw great improvement with the drug and were willing to accept what they saw as a small heart risk. "We believed they pulled the trigger far too quickly on this drug," said Roberts, president of the Irritable Bowel Syndrome Self Help and Support Group.

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