US FDA panel calls for additional CV studies for weight-loss drugs
This article was originally published in Scrip
Executive Summary
New weight-loss drugs in development could not escape the history of the notorious Fen-Phen (fenfluramine/phentermine/dexfenfluramine), which was banned from the market in 1997, at a 29 March US FDA meeting, where advisers to the agency recommended that makers of anti-obesity medicines be required to conduct additional trials to rule out cardiovascular (CV) risks, even though a product has not demonstrated a signal for that type of harm.