In March 2007, there was a recall of Zelnorm; the drug was shown to increase the risk of heart attack, stroke, and angina. However, it was made available again a few months later as an investigational new drug (IND). Since then, as of April 2008, the manufacturer of Zelnorm has decided to stop making Zelnorm available for the treatment IND program. It is still available in emergency situations, under a similar program known as an "emergency IND."
Zelnorm Recall: An Overview
Zelnorm® (tegaserod maleate) is a prescription medicine that was licensed for the treatment of irritable bowel syndrome (IBS) with constipation, as well as constipation that has lasted longer than six months with no apparent cause (known as chronic idiopathic constipation). In March 2007, Zelnorm was recalled (taken off the market) in the United States because it was shown to increase the risk for a heart attack, angina, and stroke. In July 2007, the U.S. Food and Drug Administration (FDA) announced that Zelnorm will be available to people who meet certain criteria through a special program called a "treatment IND." However, as of April 2, 2008, Zelnorm is not available under the treatment IND program (although it is now available as an "emergency IND").
What Is a Treatment IND?
The FDA can classify medications as treatment investigational new drugs (treatment INDs). These are medications that are not approved by the FDA but have been shown to provide benefit for diseases or conditions that are life threatening or for which there are no other comparable medications. Typically, these are drugs that are currently being studied in clinical trials for conditions such as cancer, HIV, or AIDS. A treatment IND makes it possible for individuals who do not qualify to participate in the clinical trials to still receive the potentially life-saving medications.
Zelnorm was classified as a treatment investigational new drug because there are no other comparable medications to treat irritable bowel syndrome (IBS) or chronic idiopathic constipation. However, the manufacturer of Zelnorm has decided to stop making Zelnorm available for the treatment IND program. It is still available in emergency situations, under a similar program known as an "emergency IND."
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Zelnorm [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation;2006 July.
Food and Drug Administration, Center for Drug Evaluation and Research. Zelnorm (tegaserod maleate) information (4/2/2008). FDA Web site. Available at: http://www.fda.gov/cder/drug/infopage/zelnorm/default.htm. Accessed April 4, 2008.
Food and Drug Administration, Center for Drug Evaluation and Research. FDA permits restricted use of Zelnorm for qualifying patients (7/27/2007). FDA Web site. http://www.fda.gov/bbs/topics/NEWS/2007/NEW01673.html. Accessed July 27, 2007.
eMedTV serves only as an informational resource. This site does not dispense medical advice or advice of any kind.
Site users seeking medical advice about their specific situation should consult with their own physician. Click