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Zelnorm® Recall After Large–Scale Study

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Zelnorm® May Increase the Risk of Heart Attacks and Strokes

Irritable–bowel syndrome or IBS is an illness in which the colon does not function adequately, resulting in severe diarrhea or constipation. Zelnorm® (tegaserod maleate) was used to treat IBS in women with the form of the disease that causes constipation. However, Zelnorm® was recalled on March 30, 2007, because it may increase the risk of heart attacks and strokes.

The Zelnorm® recall came as a result of a large study involving 18,000 participants that showed that Zelnorm® users were more likely to have heart attacks and strokes than those who did not take the drug. Novartis Pharmaceutical, the manufacturer of Zelnorm®, did not make the Food and Drug Administration (FDA) aware of this report until late in February of 2007. Zelnorm was first approved in July 2002.

Heart problems are not the only life–threatening Zelnorm® side effects. In a 20–month period, the FDA learned of 21 cases of severe diarrhea, 20 cases of ischemic colitis, and 3 cases of other types of intestinal diseases among Zelnorm® users. This prompted a Zelnorm® labeling change in April 2004, warning that Zelnorm® users could develop diarrhea or ischemic colitis, a condition that reduces blood flow to the intestines. Severe diarrhea can lead to hospitalization. Ischemic colitis can require surgery and in some cases, the condition may result in death.

Have You Been Injured by Zelnorm®?

Brayton Purcell is investigating cases of people who have been injured by Zelnorm®. If you have suffered a heart attack or stroke after taking Zelnorm®, you may be entitled to compensation. Please do not hesitate to contact us for more information. We will evaluate your case free of charge and advise you of your legal options. Many states have a deadline for filing a claim, so it is wise to learn about your legal rights as soon as possible.

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April 6, 2007
FDA Recalls IBS Drug, Zelnorm®

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Have You Been Injured by Zelnorm®?