FDA Panel Rejects Merck’s Vioxx Replacement

Calling it a “potential public health disaster,” advisors to the U.S. Food and Drug Administration (FDA) soundly refused to recommend the approval of Merck’s new painkiller Arcoxia, which the company developed to succeed <"http://www.yourlawyer.com/topics/overview/vioxx">Vioxx, a dangerous drug that was pulled from the market in 2004. (Both Vioxx and Arcoxia are in the same class of drugs, a type of non-steroidal anti-inflammatory drug (NSAID) known as COX-2 inhibitors.) At a meeting today of the FDA’s Arthritis Advisory Committee, the panel voted 20-1 against FDA approval of the drug, although that vote is non-binding and the FDA doesn’t necessarily have to follow the panel’s recommendation.

The fight against Arcoxia (etoricoxib), intended to be used to treat osteoarthritis, was led by Dr. Daniel Graham, an FDA scientist in the Office of Surveillance and Epidemiology, a part of the FDA’s Center for Drug Evaluation and Research (CDER). “What you’re talking about is a potential public health disaster,” Graham said. “We could have a replay of what we had with rofecoxib,” another name for Vioxx.

Graham and other advisors noted that Arcoxia may carry with it the same increased risk of heart attacks and strokes that plagued Vioxx; they also claim that Arcoxia is no more effective in treating arthritis pain than other safer alternatives. “There is nothing special about this drug that would warrant giving it to patients and putting them at risk of a cardiovascular death, period,” noted another committee member, Dr. David Felson of Boston University.

Sidney Wolfe, director of the Health Research Group at watchdog Public Citizen, was asked to testify at today’s committee meeting. Wolfe not only urged that Merck’s application be rejected by the FDA, but he also suggested that the drug should be pulled from the market in the 60 countries where it is currently sold. “How can the approval of etoricoxib and the large numbers of preventable, life-threatening cardiovascular adverse reactions be justified?” Wolfe asked the committee. “Why should the similarly dangerous offspring of Vioxx be approved? The answer is that it should not.”

“It is time to shut the door on further additions to this dangerous class of COX-2 inhibitor drugs,” Wolfe added. “The idea that there may be certain patients, however unidentifiable they are, who might benefit from this drug is just not good enough as a basis for its approval. In addition, further trials on these COX-2 drugs are unethical and should be stopped.”

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