Proton pump inhibitor studies outside U.S. could obviate domestic cancer risk study, companies contend.
Executive Summary
PPI FOREIGN STUDIES COULD OBVIATE NEED FOR U.S. CANCER RISK STUDY, manufacturers of the proton pump inhibitors Prilosec (Astra Merck) and Prevacid (TAP) suggested at a recent meeting of FDA's Gastrointestinal Drugs Advisory Committee to discuss the potential for increased risk of gastric cancer in Helicobacter pylori-positive patients receiving long-term proton pump inhibitor therapy.