View Full Version : FDA Says New Obesity Drugs Must Prove Absence of Cardiovascular Risk

03-30-12, 06:34 PM
Marlene Busko
30 March 2012

Drug companies should be required to submit phase 2 or 3 data to rule out excess cardiovascular risk for new obesity drugs that do not have signs or potential for precipitating cardiovascular events, FDA advisors say.

Members of the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 17 to 6 in favor of these requirements, after much discussion evaluating the implications of this new approach. The meeting was restricted to focusing on obesity drugs without a theoretical risk or signal for cardiovascular harm.

Read more: http://www.medscape.com/viewarticle/761266

03-30-12, 06:35 PM
I think I'm going to faint! The advisory committee is showing some common sense? No way, I must have read this wrong :) Do read the article to see some rationales for voting against this requirement.