BUFFALO, N.Y. (CN) – A woman says she suffered a “severe stroke” after taking Zelnorm, a Novartis drug prescribed for irritable bowel syndrome and constipation. The drug was pulled off the market when the FDA said its risks outweighed the benefits.
Analysis of 29 clinical studies showed that patients taking Zelnorm were eight times more likely to have heart attacks or strokes than those taking placebos, Laurie Litwiniak says in her federal complaint.
Zelnorm was prescribed in 55 countries and brought in $561 million in 2006. Zelnorm is the brand name of tegaserod maleate, a serotonin receptor that stimulates the release of certain chemicals in the intestines that increase the movement of stools through the bowel.
Initially rejected by the FDA, the drug won approval in 2002 when it was determined the side effects were not enough to keep it from hitting the market. It was prescribed to women under 65 who had irritable bowel syndrome, abdominal discomfort, constipation and bloating.
Two years after its approval, the FDA widened the range of Zelnorm patients to men, patients over 65 and those suffering from severe diarrhea.
Litwiniak claims that Novartis downplayed the “serious and life-threatening side effects” when information began to emerge in 2007.
Clinical studies included more than 11,000 patients treated with Zelnorm and more than 7,000 with a sugar pill. Among the patients taking the sugar pill, only one had symptoms suggesting the beginning of a stroke, which eventually went away without complications, according to the complaint. But 13 Zelnorm patients suffered heart attacks, severe chest pain or strokes, resulting in one death, according to the complaint.
Novartis submitted the analysis of the clinical trials to the FDA, which concluded that the benefits of taking Zelnorm did not outweigh its risks, and ordered Novartis to stop selling the drug.
Litwiniak seeks damages for product liability, negligence and fraud.
She is represented by Clinton B. Fisher with Hanly Conroy Bierstein in Manhattan and Michael W. Heaviside with Ashcraft & Gerel in Washington, D.C.