December 1, 2008Woman in Iowa files Zelnorm lawsuit against manufacturer
An Iowa woman has filed a lawsuit against the manufacturer of the irritable bowel syndrome drug Zelnorm, alleging that the drug caused her to suffer permanent heart problems. The Food and Drug Administration ordered Novartis Pharmaceuticals to recall Zelnorm in 2007 after studies showed it caused an increased risk of cardiovascular side effects.According to the Zelnorm lawsuit filed by her attorney, Ginger Marolf used Zelnorm from 2002 to 2007. Although she had no history of heart disease before using the drug, Marolf experienced cardiovascular problems after using it that required the placement of stents in her body.
Marolf alleges that even though studies beginning in 2004 indicated that Zelnorm could cause an increased risk of heart problems, Novartis hid this information from doctors and their patients until the drug was finally withdrawn. The FDA told Novartis to take Zelnorm off the market in March 2007 after a study found that patients taking the drug had an increased risk of heart attack, stroke and chest pain compared with patients who were given a placebo.
Although the FDA permitted the limited use of Zelnorm for women younger than 55 in July 2007, the agency reversed this decision in April 2009 due to the drug’s side effects risk. Currently, Zelnorm can only be prescribed in cases where a patient’s life would otherwise be in danger.