FDA Allows Zelnorm Sales to Women Who Fit Certain Guidelines

The US Food and Drug Administration (FDA) announced today that it is permitting the restricted use of Zelnorm under what is known as an 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. These patients must meet strict criteria and have no known or pre-existing heart problems and be in critical need of the drug. Zelnorm will remain off the market for general use - Learn Why Here and Here.

Medical professionals with IBS-C or CIC patients who meet the IND criteria should contact Novartis at 888-669-6682 or 800-QUI-NTILE.

Those who do not qualify for the Zelnorm treatment protocol (see above for criteria) can contact the FDA's Division for Drug Information about other options at 888-463-6332.

Zelnorm Recall Information

(UPDATE 7.27.2007): The US Food and Drug Administration (FDA) announced today that it is permitting the restricted use of Zelnorm to treat women younger than 55 who meet specific guidelines. Read More Here.

US Recall News reported on the Zelnorm Recall the day it was announced by the FDA. Click here to read the original Zelnorm Recall post, which includes information bout the dangers of taking Zelnorm (tegaserod maleate) and side effects.

If you would like more information than this, however, we suggest discussing this with a qualified doctor.

In the meantime, here is the official contact info for the company who makes Zelnorm, and by visiting the official Zelnorm website:

Novartis Pharmaceuticals Corporation
One Health PlazaEast
Hanover, NJ 07936

Novartis Pharmaceuticals Phone:
(888-669-6682)

For more information about the Zelnorm recall or to speak with a Zelnorm side effects attorney, please contact Jacoby & Meyers. The attorneys at Jacoby & Meyers are accepting Zelnorm injury claims nationwide.