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FDA Panel Rejects Vioxx Replacement

April 13, 2007

COX-2 Drugs • Bextra • Celebrex • Vioxx --- News • Celebrex May Disrupt Heart Rhythm • FDA Rejects Arcoxia As Arthritis Drug • FDA Panel Rejects Vioxx Replacement • FDA Panel Members Indebted to Drug Companies • COX-2 Painkillers Restricted in Europe • Researchers Ignored Early COX-2 Warnings • FDA to Improve Drug Safety Monitoring • FDA Convenes COX-2 Meeting • FDA Blasts Ads For Celebrex, Bextra • Feds Issue Caution On All COX-2 Drugs • British Heart Patients Told to Stop Taking Cox-2 Drugs • Researchers Warn of Dangers

Merck & Co. appears unlikely to win approval for a new arthritis drug after a Food and Drug Administration advisory panel voted overwhelmingly to keep it off the market. Merck had hoped to make Arcoxia a replacement for the withdrawn Vioxx.

Both drugs are so-called Cox-2 inhibitors. Vioxx was withdrawn from the market in September 2004 after tests showed it doubled the risk of heart attack and strokes in people taking it.

In making its recommendation, the FDA panel said it could see no value in making Arcoxia available to arthritis sufferers. In fact, panelists said it likely posed the same cardiovascular risks as Vioxx and other Cox-2 drugs that have been pulled from the market.

The drug maker has promoted Arcoxia as safe as other pain relievers on the market and argued that it would be a valuable alternative for arthritis patients who have few other options.

Since Vioxx was withdrawn, Merck has faced a barrage of lawsuits charging injury and wrongful death. The FDA has faced mounting criticism over its drug approval process, with critics charging Vioxx should never have been approved in the first place.

The FDA panel vote rejecting Arcoxia was 20-1.

Merck withdrew Vioxx in 2004, following indications that it can contribute to serious cardiovascular events including heart attacks and strokes.

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