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Medication Re-release Alert

July 27, 2007

ISSUE:FDA Permits Restricted Use of Zelnorm for Qualifying Patients
MEDICATION:ZelnormŽ (tegaserod), Novartis Pharmaceuticals

The following was excerpted from the FDA Med Watch alert website dated July 27, 2007:

"The U.S. Food and Drug Administration announced that it is permitting the restricted use of Zelnorm (tegaserod maleate) under a treatment investigational new drug (IND) protocol to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55 who meet specific guidelines. In some instances, patients with a serious or life-threatening disease or condition who are not enrolled in a clinical trial may be treated with a drug not approved by the FDA. Generally, such use is allowed within guidelines called a treatment IND, when no comparable or satisfactory alternative drug or therapy is available. In addition to the age and gender restrictions, the IND protocol for Zelnorm limits use of the drug to those with IBS-C or CIC whose physicians decide the drug is medically necessary. Patients must sign consent materials to ensure they are fully informed of the potential risks and benefits of Zelnorm. On March 30, 2007, the FDA asked Novartis, the manufacturer of Zelnorm, 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). At that time, the FDA indicated that there might be patients for whom the benefits of Zelnorm treatment outweigh the risks and for whom no other treatment options were available. FDA committed to work with Novartis to allow access to Zelnorm for those patients through a special program. That work yielded this IND protocol."


Selected responses from the Novartis "Frequently Asked Questions About The Treatment IND":

How do patients/physicians enroll in the treatment IND program?

Female IBS-C or CIC patients under 55 seeking to enroll should contact their physicians to inquire about the protocol and evaluate if they meet the FDA-approved criteria. For further details of the program's protocol, physicians can call 866-248-1348 or 888-669-6682.

What is the cost of Zelnorm through this treatment IND?

If a patient is approved for the Zelnorm treatment IND , Novartis will provide Zelnorm at no cost to the patient.

Should patients take Zelnorm under the treatment IND program given the reported cardiovascular events?

This program was established in response to requests to Novartis and the FDA from patients and physicians following the marketing suspension earlier in the year. The program materials are designed to help ensure that physicians are fully informed of the potential risks and benefits of Zelnorm, and can make appropriate medical judgments about whether the drug makes sense for their individual patients. Patients will also receive materials about the potential risks and benefits, to allow them to make an informed consent to participate. In addition, the treatment IND will not include patients who have cardiovascular ischemic disease or cardiovascular risk factors.

What are the Zelnorm treatment IND inclusion criteria?

Key inclusion criteria include:

  • Women under the age of 55 years
  • Currently suffering with IBS-C or Chronic Idiopathic Constipation
  • No satisfactory response to other available treatments and/or patients who had satisfactory improvement of their symptoms with prior Tegaserod treatment
Key exclusion criteria include:
  • History or current diagnosis of cardiovascular ischemic disease
  • Symptoms suggestive of cardiovascular ischemic disease
  • Presence of any cardiovascular risk factors according to NIH guidelines
  • Uncompensated depression or anxiety or suicidal ideation or behavior

To become part of this program, patients should contact their physicians to inquire about the protocol and evaluate if they meet the criteria.