 |
 |
 |
|
 |
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
Consumer Update |
On July 27, 2007, FDA announced that it is permitting the restricted use of Zelnorm (tegaserod maleate) to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55 who meet specific guidelines.
Zelnorm is restricted to use under a treatment investigational new drug (IND) protocol.
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 FDA. Generally, such use is allowed within guidelines called a treatment IND, when no comparable or satisfactory alternative drug or therapy is available.
FDA approved Zelnorm in 2002. On March 30, 2007, FDA asked Novartis, the manufacturer of Zelnorm, to suspend its U.S. marketing and sales because a safety analysis found a higher chance of serious symptoms in people treated with Zelnorm compared to treatment with an inactive substance (placebo). These symptoms are
In March 2007, FDA indicated that the benefits of Zelnorm treatment may outweigh the risks for certain people that did not have any other treatment options. FDA committed to work with Novartis to allow access to Zelnorm for those patients through a special program. That work resulted in the IND protocol.
"These patients must meet strict criteria and have no known or pre-existing heart problems and be in critical need of this drug," says Steven Galson, M.D., M.P.H., Director of FDA's Center for Drug Evaluation and Research. "Zelnorm will remain off the market for general use."
Irritable bowel syndrome is a disorder characterized most commonly by
IBS causes a great deal of discomfort and distress, but it does not permanently harm the intestines and does not lead to disease. For some people, however, IBS can be disabling. They may be unable to work, attend social events, or even travel short distances.
People are considered to have chronic constipation if they have fewer than three complete spontaneous bowel movements per week and at least one of the following symptoms for at least 25% of those bowel movements:
Physicians who have IBS-C or CIC patients who meet the IND criteria should contact Novartis at 888- 669-6682 or 866-248-1348. Those who do not qualify for the Zelnorm treatment protocol may contact FDA's Division for Drug Information about other options at 888-463-6332.
Novartis Zelnorm Web page
www.zelnorm.com
National Institute of Diabetes and Digestive and Kidney Diseases—Irritable
Bowel Syndrome
http://digestive.niddk.nih.gov/ddiseases/pubs/ibs/
International Foundation for Functional Gastrointestinal Disorders
www.iffgd.org
FDA Center for Drug Evaluation and Research
www.fda.gov/cder
Date Posted: July 27, 2007
