Zelnorm, a drug designed to combat irritable bowel syndrome, has been withdrawn from the market at the request of the FDA.
The FDA reviewed 29 Zelnorm studies that demonstrated a greater risk for heart attack and stroke in patients treated with Zelnorm compared with a control groups given a placebo.
The studies found 13 cases of heart attack, stroke, or angina (chest pain related to heart disease) of the 11,600 patients who took the Zelnorm. The control group of 7,000 had only one similar non-fatal adverse event.
This development does not come as a shock to pharmaceutical lawyers or consumer advocate groups. In March 2001, Public Citizen urged the FDA to reject Zelnorm because was not efficacious in treating patients with irritable bowel syndrome and because of serious safety concerns. Zelnorm was also rejected as too risky last year for a second time by a European Union health advisory panel. Yet the FDA approved the drug in 2002.