Pondering Vioxx: Easier on Stomach, Harder on Heart?
Remember one thing in medicine–there is no miracle cure and anything that is advertised as the best thing since slice whole grain bread-you can bet there’s some major side effects. So, when it comes to joint pain relievers, you can take one of the new COX-2 inhibitors and maybe have less chance of death from bleeding ulcers, but you may die of a fatal MI instead. Some choice, huh? How about exercise, chiropractic care, glucosamine, chondroitin, MSM instead?
Joint Letter 7(4):37,44-46, 2001 Pharmaceutical giants Pharmacia and Merck recently petitioned the U.S. Food and Drug Administration (FDA) to relax gastrointestinal (GI) safety warnings on the labels of their respective COX-2 inhibitors. Last month, we reported on Pharmacia’s submission for celecoxib (Celebrex). This month, we examine Merck’s request for rofecoxib (Vioxx). As of press time, the FDA had not issued a final decision.Vioxx is easier on the stomach than generic naproxen. But it may be harder on the heart, according to recent briefings presented to the U.S. Food and Drug Administration’s Arthritis Advisory Committee.On February 8, representatives from Merck presented data to the advisory committee from Merck’s huge randomized VIGOR trial, which compared Vioxx to the nonsteroidal anti-inflammatory drug (NSAID) naproxen in 8076 patients with rheumatoid arthritis (RA). The advisory committee also heard from the FDA’s own in-house analysts, who offered interpretations of the VIGOR data that sometimes conflicted with Merck’s. After factoring in all the safety data on GI benefits and cardiovascular risks, the FDA’s medical officers concluded that the highly touted COX-2 inhibitor was no safer than naproxen. They recommended the Vioxx label be modified to include more cautions, rather than fewer. “To a patient it, doesn’t matter whether you end up in an intensive care unit with a big GI bleed or whether you end up in an intensive care unit with a myocardial infarction,” noted advisory committee member Steven Nissen, MD, reflecting this concern. “They are both pretty bad things to have happen.”