Word: vioxx
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...much as $2 to $3 a day), and many doctors felt the drugs were being hyped far beyond their medical value. "These agents have been the subject of absolutely intensive, unrelenting marketing," Wofsy says. Even if you don't have arthritis, you can probably hum the Celebrex jingle or Vioxx's It's a Beautiful Morning theme...
...none of the other COX-2 inhibitors have been tarred with Vioxx's brush. Pfizer's Celebrex has been studied the longest; some patients in three ongoing Celebrex trials have been followed for several years without any signs of cardiovascular effects. Bextra, also from Pfizer, hasn't been tested as long, but so far the data look good. Two more COX-2 inhibitors, Arcoxia (from Merck) and Prexige (from Novartis), are awaiting FDA approval. "Obviously, we now have to look more carefully at the other members of the class," says Dr. Steven Nissen, a cardiologist at the Cleveland Clinic...
...first hint that there might be a problem with Vioxx surfaced in 2000, just a year after the drug won FDA approval. A study that compared Vioxx with naproxen (the active ingredient in Aleve) showed that Vioxx cut gastrointestinal problems in half but increased the risk of heart attack from 0.1% to 0.4%. Those results were ambiguous, though. Was Vioxx causing the heart attacks, or was naproxen protecting the heart? Few experts fault Merck for continuing to market Vioxx on the basis of that study alone...
...evidence didn't stop there. Subsequent studies based on reviews of large numbers of clinical records continued to show troubling indications. The final straw was a piece of research that Merck conducted. It was a particularly careful study--a randomized, double-blind trial of 2,600 patients, comparing Vioxx with a placebo--designed to determine whether Vioxx might prevent the formation of polyps in the colon. The study was scheduled to last three years, but two weeks ago, the panel of doctors and statisticians that was monitoring the trial's safety data informed Merck that the evidence of cardiovascular problems...
...what should you do if you have a bottle of Vioxx in your medicine cabinet? "For younger patients who are otherwise well, I think you can afford to wait until you talk to your doctor," says Dr. Meggan Mackay, a rheumatologist at Columbia Presbyterian Medical Center in New York City. Older patients, particularly those with a history of heart disease, should stop taking the drug immediately and consult their doctor about a new treatment. But don't throw away your bottle; Merck has promised to reimburse customers for unused medication. For more information, call 1-888-36-VIOXX...