FDA announces restricted access program for Zelnorm

Yael Waknine

July 27, 2007

Rockville MD - Restricted use of tegaserod maleate (Zelnorm, Novartis) will be allowed under an investigational new drug (IND) protocol program, the US FDA announced today [1].

Although tegaserod maleate was suspended from the US market in March, when a safety analysis linked its use to an increased risk for cardiovascular ischemic events, the product may still benefit certain patients who have no other treatment options.

"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," the agency notes in a news release. "Generally, such use is allowed within guidelines called a treatment IND, when no comparable or satisfactory alternative drug or therapy is available."

Under the IND protocol, tegaserod may be used only to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55 years, according to an alert sent from MedWatch, the FDA's safety information and adverse-event reporting program. Strict criteria further limit its use to patients in critical need who have no known or preexisting heart problems.

Physicians with IBS-C or CIC patients who meet the IND criteria are encouraged to contact the manufacturer by phone at 888-669-6682 or 800-QUI-NTILE. Information regarding alternative therapeutic options for patients who do not meet the criteria may be obtained from the FDA's Division for Drug Information at 888-463-6332.

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