On April 1, the Food and Drug Administration contacted Novartis Pharmaceuticals with a request to discontinue marketing for their irritable bowel syndrome medication Zelnorm. The FDA issued this voluntary request based upon recent findings that Zelnorm increased its users risk of serious heart problems.
According to a public advocacy group called Public Citizen, this was old news to both the FDA and Novartis. The group had protested the drugs release arguing that its risks outweighed its marginal benefits. Other than heart trouble, Zelnorm also increased the risk of ovarian cysts and fainting spells.
Dr. Sidney Wolfe, M. D. , director of Public Citizen's Health Research Group said, “We noted in this petition that receptors with which this drug interacts exist not only in the intestinal tract . . . but also in the heart. We pointed out that cisapride, a gastrointestinal drug which also caused fainting and was taken off the market because of cardiac arrhythmias, also affected this same receptor in the heart. ”
According to ConsumerAffairs.com, “Zelnorm was approved by the FDA in July 2002 for short-term treatment of women with irritable bowel syndrome whose primary symptom is constipation. It was subsequently approved in August 2004 for treatment of chronic constipation for men and women under age 65. Zelnorm is currently marketed in 55 countries. ”
The FDA has had many high profile mistakes in the past, and has proved that their provision over the drug industry is marginal at best. Time and time again the FDA has failed to put the interest of the American people in front of big pharma.
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Joshua Daly is the author of many health related articles as well as the President of ePharmacies.com. Joshua's goal is to help consumers save money and make better informed decisions. Click here for more information on ordering from a discount online pharmacy .