Zelnorm Linked to Cardiovascular Side Effects

\On March 30, 2007, The FDA ordered that Novartis Pharmaceuticals Corporation, "willingly" stop marketing Zelnorm (generic: tegaserod) based on the recent findings of an increased risk of serious cardiovascular adverse events (heart problems) associated with use of the drug. Accordingly Novartis has agreed to voluntarily suspend marketing of the drug in the United States. The FDA is currently advising patients who are using Zelnorm to get in touch with their health care providers to discuss treatment alternatives. Patients who are taking Zelnorm should seek emergency medical care 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.

Throughout February and March 2007, Novartis reported to FDA the results of a new analysis of 29 short-term (1 - 3 months) randomized, controlled clinical trials of Zelnorm. The FDA concluded, based on the data that for most patients the benefits of this drug no longer outweigh the risks. The analysis included more than 11,600 patients treated with Zelnorm and over 7000 patients treated with placebo. The data showed that the risk of serious cardiovascular adverse events (e.g., angina, heart attacks, and strokes) associated with use of Zelnorm is higher than with placebo treatment. Thirteen Zelnorm-treated patients (or 0.1%) had confirmed cardiovascular ischemic events, and only 1 placebo-treated patient (or 0.01%) with an event.

Additionally, Zelnorm has been linked to serious cases of diarrhea, ischemic colitis and potentially death. As a result, the FDA has ordered that a precaution about the intestinal condition go on Zelnorm's label, along with a larger warning about severe diarrhea. Zelnorm is used to speed the colon's movement of stools.

The FDA has received 21 reports of diarrhea so severe that it caused such complications as low blood pressure and fainting. Sixteen of these patients required hospitalization. The FDA has received 20 reports of ischemic colitis, plus three reports of a similar intestinal problem. Fourteen patients were hospitalized and four died.

Zelnorm should not be used by anyone who frequently experiences diarrhea, and should be stopped immediately if patients get dizzy or faint, the FDA said.

Irritable bowel syndrome is a mysterious disorder that gives millions of people, mostly women, abdominal pain and either severe diarrhea or constipation or both. Zelnorm is the only FDA-approved therapy for the constipation-causing form of the ailment. It is supposed to be used only by women.

If you or a loved one took Zelnorm and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.

Have you had a severe reaction or side effects from Zelnorm?

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