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FDA Alert – FDA Permits Restricted Zelnorm Use

The FDA announced it’s permitting the restricted use of Zelnorm under 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 this drug. Zelnorm will remain off the market for general use.

The Bottomline:
Physicians 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 may contact FDA's Division for Drug Information about other options at 888-463-6332.

Read the complete MedWatch 2007 Safety Summary including a link to the FDA News at: www.fda.gov/medwatch/safety/2007/safety07.htm#Zelnorm

MedWatch is your Internet gateway for timely safety information on drugs and other medical products regulated by the U.S. Food and Drug Administration. To see the latest official safety information or to report serious adverse events, visit our website: www.fda.gov/medwatch