FDA Advisers Give Overwhelming Rejection to Etoricoxib (Arcoxia) April 13, 2007 MedPage Today, April 12, 2007 GAITHERSBURG, Md. -- By a vote 20 to one, FDA advisers recommended today against approval of Merck's Cox-2 inhibitor etoricoxib (Arcoxia). The FDA's Arthritis Drugs Advisory Committee declared that the cardiovascular risks of the drug outweigh its benefits for easing arthritis pain. Richard Cannon, M.D., a National Heart, Lung, and Blood Institute cardiologist, and a member of the committee, said he was convinced there was a cardiovascular risk with the drug "and it comes down to determining whether there is a clinical need for this drug." In the final analysis, Dr. Cannon said, Merck failed to convince him and other panel members that "there's a need for this drug in addition to what's already available." P. Jay Pasricha, M.D., of the University of Texas Medical Branch at Galveston, cast the only yea vote for the drug, but he even he qualified his approval by saying that it should include a strict medical management program that would limit access to the drug. « Back | The Newsroom »