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An arthritis drug exalted by its manufacturers as the replacement for its Vioxx – which has been pulled from the market because of the cardiovascular risks associated with its use – is now thought to be just as dangerous by a number of doctors.

“If it's approved, I believe people will be hurt,” said chairman of cardiovascular medicine at the Cleveland Clinic, Steven Nissen, speaking of Arcoxia.

A Food and Drug Administration advisory panel is set to review the information about the drug and decide if it is safe and effective enough for use by the general patient population. While the agency is not bound to obey panel recommendations, it usually does go with what it says.

Arcoxia Seeks Approval

Arcoxia is a COX-2 inhibitor similar to Vioxx and Celebrex. They are pain relievers advertised to cause fewer gastrointestinal side effects than other painkillers, such as non-steroidal anti-inflammatory drugs (NSAIDs), like ibuprofen and naproxen.

Merck, maker of Vioxx, is seeking the approval of its new painkiller Arcoxia, which is already sold in Europe, Asia and Latin America.

Studies have been done to test its safety, but they have been criticized for comparing Arcoxia to the older NSAID, diclofenac.

The study compared the rates of cardiovascular events in users of Arcoxia to those in users of diclofenac and found them to be similar, but past research suggests that may not be a good thing.

An analysis last year found that diclofenac may be just as risky to the cardiovascular system as the lower marketed dose of Vioxx.

The analysis looked at data from 23 studies and found that only Naproxen (sold as Aleve) was found not to raise cardiovascular risks.

The director of cardiovascular health research unit at the University of Washington, Bruce Psaty, said manufacturers can “fix” trials by comparing them to drugs known to be weak. “It makes their drug look good or comparable but doesn't provide much in useful public health information,” he said.

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