Special Alerts:

[UPDATE 07/27/2007] FDA announced that it is permitting the restricted use of tegaserod (Zelnorm) 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. These patients must meet strict criteria and have no known or pre-existing heart problems and be in critical need of this drug. Tegaserod will remain off the market for general use. 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 tegaserod treatment protocol may contact FDA's Division for Drug Information about other options at 888-463-6332. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Zelnorm and http://www.fda.gov/bbs/topics/NEWS/2007/NEW01673.html.

[Posted 03/30/2007] FDA notified healthcare professionals and patients that Novartis has agreed to discontinue marketing tegaserod (Zelnorm), a drug used for the short-term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 years of age with chronic constipation. FDA analysis of safety data pooled from 29 clinical trials involving over 18,000 patients showed an excess number of serious cardiovascular adverse events, including angina, heart attacks, and stroke, in patients taking tegaserod compared to patients given placebo. Patients taking tegaserod should contact their healthcare professional to discuss treatment alternatives and seek emergency medical care if they experience severe chest pain, shortness of breath, sudden onset of weakness or difficulty walking or talking, or other symptoms of a heart attack or stroke. Healthcare professionals should assess their patients and transition them to other therapies as appropriate. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Zelnorm and http://www.fda.gov/cder/drug/advisory/tegaserod.htm.