An Iowa woman who took Zelnorm, a medication that has since been removed from the market, has filed suit against Novartis, the company that made the drug, saying she suffered serious, adverse side effects. The 35-year-old Plaintiff, who took Zelnorm from 2002 through 2007, when it was discontinued for general use, filed the lawsuit on behalf of herself and her son in federal court. Zelnorm was used to treat irritable bowel syndrome. It’s alleged in the complaint that Novartis “knew or should have known” of an increased risk of heart problems because of information from studies that began in 2004. The lawsuit alleges:
Even though Novartis became aware of information concerning increased cardiovascular risk from Zelnorm use following the initial approval of Zelnorm in 2002, Novartis concealed this information from consumers, including Plaintiff, and from their physicians and the FDA until Zelnorm was withdrawn from the market in 2007.
The FDA approved Zelnorm for use in July 2002. The FDA requested Novartis take the drug off the shelf in March 2007. The FDA says on its website that an analysis found a higher chance of heart attack, stroke and chest pain in patients treated with Zelnorm compared with people treated with a placebo. But, FDA officials said there may be women for whom the benefits of Zelnorm outweighed the risks. In July 2007, the FDA allowed for a limited use of the drug in specific women younger than age 55. However, that changed again in April. Now, the drug will be prescribed only when a person’s life is in danger.
The Plaintiff in the recently-filed lawsuit, who had no history of heart disease, developed problems that have required angioplasty and the placement of stints. It’s alleged in her lawsuit that her condition “will continue to profoundly and adversely impact her and her son for the rest of their lives.” This case will be watched with interest. If you need additional information on Zelnorm contact Frank Woodson with our firm at 800-898-2034.
Source: Quad City Times
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