FDA Advisory Panel Rejects Vioxx Successor

THURSDAY, April 12 (HealthDay News) -- The proposed successor to the banished arthritis painkiller Vioxx was soundly rejected Thursday by an advisory committee to the U.S. Food and Drug Administration.

Expressing concern over the cardiac safety of the new prescription drug, Arcoxia, the panel of medical experts voted 20-1 to recommend against approval of it. The FDA does not have to follow the recommendations of its advisory committees, but it usually does.

"Just having a similar drug in the market is no reason to approve this drug or any other similar drug," Dr. Robert Meyer, director of the FDA's Office of Evaluation in its Center for Drug Evaluation and Research, said after the vote.

Meyer told a news conference that the panel wanted any new non-steroidal anti-inflammatory drugs, which include cox-2 painkillers like Vioxx and Arcoxia, to undergo head-to-head comparisons to similar drugs before applying for U.S. approval.

The action by the FDA's Arthritis Advisory Committee was preceded by a barrage of criticism over Arcoxia's potential risk for increasing heart attacks and strokes, particularly among people with existing heart disease.

Arcoxia, made by Merck & Co., is a cox-2 inhibitor designed to treat the pain of osteoarthritis without the harsh stomach effects associated with painkillers such as aspirin.

It was also Merck's planned successor candidate to Vioxx, which was pulled from the market in 2004 because of the increased risk for heart attack and stroke linked to it.

FDA scientist Dr. David Graham testified before the panel Thursday that the drug safety studies done on Arcoxia (etoricoxib) were neither adequate nor reasonable to support its approval, theAssociated Pressreported.

"What you're talking about is a potential public health disaster," Graham said of Arcoxia. "We could have a replay of what we had with rofecoxib [Vioxx]."

Another strong critic, Dr. Eric J. Topol, director of the Scripps Translational Science Institute, also found fault with the new drug. Topol first published data on the danger of Vioxx in 2001.

"We don't have the data to know the boundaries of Arcoxia's safety," he said in an interview Thursday before the vote. "There is a difference now that there is awareness of heart risk with these drugs. There was not awareness, in fact, there was denial back in 2001."

"If the drug is approved, it would not be the same as what happened years ago," he added. "But I still am concerned that we don't have the cardiovascular safety issue assured. There can be misrepresentation of the drug when it's marketed."