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Zelnorm

Novartis Pharmaceuticals’ irritable bowel syndrome drug—Zelnorm (tegaserod maleate)—was pulled from the United States market in March 2007 when the Food and Drug Administration received the results of a large-scale analysis linking the drug to an increased risk of serious cardiovascular problems including heart attack and stroke. The FDA has since urged patients still taking Zelnorm to seek medical attention immediately if they experience chest pains, shortness of breath, dizziness, or other heart attack or stroke symptoms.

Zelnorm’s maker has agreed to stop sales of the drug, but this does little to help those who have already suffered injury as a result of taking it. If you or a loved one has suffered a cardiovascular event or other serious side effect while taking Zelnorm, you may be able to hold Novartis responsible for your losses. To learn more about recovering compensation for your injuries, please contact us today.

Zelnorm Problems

Zelnorm has a history of problems dating as far back as March 2001 when the consumer rights organization Public Citizen filed a petition to block the drug’s approval because of safety concerns. Despite the group’s objections, the FDA approved Zelnorm for short-term use in women suffering from constipation-predominant IBS in July 2002.

Just two years after its initial approval, the drug’s label was revised to include a heightened warning about the risk of severe diarrhea and ischemic colitis, a severe intestinal problem. The FDA expanded the drug’s uses to include chronic idiopathic constipation in women under the age of 65 in August 2004, but several years later, the safety of the drug was questioned again. Immediately prior to the March 30th recall, Zelnorm’s label was updated to include an additional side effect—changes in liver functioning.

Additional Zelnorm problems surfaced after the results of 29 studies involving more than 18,000 patients revealed a heightened risk of:

  • Angina
  • Heart attack
  • Stroke

According to analysis of the studies, .11 percent of Zelnorm users experienced a serious heart problem—one of which was fatal—compared with only .01 percent of patients taking a placebo.

Are You Entitled to Compensation?

If you or someone you love has suffered injury as a consequence of taking Zelnorm, you may be entitled to financial reimbursement for your losses and suffering. Please contact us today to learn more about the legal remedies available to you from an experienced attorney in your area.

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