The FDA, on March 30, 2007, announced that Zelnorm, the popular drug for irritable bowel syndrome and constipation was pulled from the market amid new studies linking the drug to an increased risk of heart attacks and strokes.

Novartis Pharmaceuticals Corporation of East Hanover, New Jersey agreed to discontinue marketing its GI drug, Zelnorm (tegaserod maleate) due to recent findings of an increased risk of serious cardiovascular adverse events (heart problems) associated with use of the drug.

Zelnorm is a prescription medicine used to treat women with irritable bowel syndrome whose primary symptom is constipation and to treat patients (men & women) younger than 65 years with chronic constipation. Zelnorm is marketed in 55 countries around the globe.

John Jenkins, M.D., head of the FDA's office of New Drugs told reporters that "the rate of cardiovascular events - about 10 times higher in patients taking Zelnorm - raised alerts about the drug." He said patients taking Zelnorm should immediately speak to their doctors.

Douglas Throckmorton, Deputy Director for the Center for Drug Evaluation and Research said about the announcement, "[h]ere a potential risk of very serious harm to patients who have this non-life-threatening condition was recently identified, making this action necessary."

The FDA is currently advising patients who are using Zelnorm to contact their physicians to discuss treatment alternatives. Patients who are taking Zelnorm should seek emergency medical care right away if they experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking or other symptoms of a heart attack or stroke.

Zelnorm has also been linked to ischemic colitis, mesenteric ischemia, gangrenous bowel, rectal bleeding, syncope (light headedness or fainting), bile duct stones, serious diarrhea and potentially death.

FDA Public Health Advisories are available online.