August 27, 2009New York woman who suffered stroke files Zelnorm lawsuit
A New York woman has filed a lawsuit against the manufacturer of the irritable bowel syndrome medication Zelnorm, alleging that she suffered a stroke as a result of the drug’s side effects. Laurie Litwiniak’s lawsuit alleges that Novartis Pharmaceuticals downplayed the risks of taking Zelnorm after reports about the dangers of the drug began to emerge in 2007.Zelnorm was approved by the Food and Drug Administration in 2002 for the treatment of digestive disorders, including constipation, abdominal discomfort and irritable bowel syndrome. The drug was primarily marketed to women under 65 who suffered from these conditions, although the FDA later allowed older patients and men to be prescribed Zelnorm.
Zelnorm was withdrawn from the market in March 2007 after it was found the drug could cause an increased risk of heart attack, stroke or other serious cardiovascular side effects. Data from 29 clinical studies of the drug found that Zelnorm users were eight times more likely to suffer a heart attack or stroke than patients taking a placebo. As a result, the FDA told Novartis to take Zelnorm off the market, stating that the risks of taking the drug outweighed its potential benefits.
Researchers have criticized Novartis’ $249 million ad campaign to promote Zelnorm, charging that many patients were prescribed the drug unnecessarily as a result of viewing TV ads to promote it. A study by researchers at the University of North Carolina-Chapel Hill found that one million patients visited their doctors as a result of the advertisements during their first three months on the air, resulting in as many as 400,000 new diagnoses of irritable bowel syndrome.