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Recess Appointment for Dudley Puts Public at Risk

* On April 12, a Food and Drug Administration (FDA) panel voted overwhelmingly not to approve the Merck painkiller Arcoxia. On April 28, the FDA rejected Merck’s application.

April 12, 2007

FDA Should Not Approve Painkiller Dubbed “Offspring of Vioxx”

It’s Time to Shut the Door on COX-2 Inhibitors, Dr. Sidney Wolfe of Public Citizen Tells FDA Advisory Committee

WASHINGTON, D.C. – Public Citizen today urged the government to reject an application for a new painkiller – Arcoxia – that is in the same class of drugs as Vioxx and, like that drug, is associated with an increased risk of cardiovascular problems.

In testimony to the Food and Drug Administration’s (FDA) Arthritis Advisory Committee, Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, said the drug should not be approved for sale in the United States, and, in fact, should be pulled from the market in the more than 60 countries where it is sold.

Arcoxia, whose generic name is etoricoxib, is a COX-2 inhibitor – a kind of painkiller once touted as a miracle cure for osteoarthritis because it was supposed to be easier on the stomach. However, data show that COX-2 inhibitors increase the risk of heart attack and other cardiovascular events. One COX-2 inhibitor, Vioxx, was pulled from the market in 2004 after studies linked it to increased risks of heart attack and stroke.

In randomized trials, etoricoxib was associated with increased cardiac risks when compared to naproxen. Further, with regards to serious gastrointestinal problems, there is no evidence of benefits of taking etoricoxib compared to diclofenac, a non-steroidal anti-inflammatory drug. Therefore, etoricoxib offers no unique benefits but carries a risk not associated with older pain relievers.

“How can the approval of etoricoxib and the large numbers of preventable, life-threatening cardiovascular adverse reactions be justified?” Wolfe asked. “Why should the similarly dangerous offspring of Vioxx be approved? The answer is that it should not.”

Wolfe pointed out that trial data presented by Merck on cardiovascular risks compared etoricoxib with diclofenac, which is much more cardio-toxic than older, safer pain relievers.

“It is time to shut the door on further additions to this dangerous class of COX-2 inhibitor drugs,” Wolfe said. “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.”

To read Wolfe’s testimony, click here.