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FDA Advisory Panel Rejects Vioxx Successor

Merck's new painkiller Arcoxia shows cardiac risk, committee says in 20-1 vote.

THURSDAY, April 12, 2007 (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, the Associated Press reported.

"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."

A top Merck official told the advisory panel that the company has "comprehensively characterized the safety and efficacy profile" of Arcoxia.

"We at Merck believe etoricoxib represents a valuable treatment option for patients with osteoarthritis. We would like to emphasize there is more long-term safety data ... for etoricoxib than any other NSAID," said Peter Kim, president of Merck's research laboratories.

But other experts were not convinced.

In prepared testimony for the panel, Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, said the drug should not approved in the United States and should be pulled from the market in the more than 60 countries where it is now sold.

"How can the approval of etoricoxib and the large numbers of preventable, life-threatening cardiovascular adverse reactions be justified?" Wolfe said in a prepared statement. "Why should the similarly dangerous offspring of Vioxx be approved? The answer is that it should not."

Wolfe noted that trial data presented by Merck on cardiovascular risks compared etoricoxib with the arthritis pain reliever diclofenac (brand name Voltaren), which he said 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."

Earlier this week, the FDA staff had concluded that if safer alternatives were available, U.S. regulators should not approve new painkillers in the same class as Vioxx.

The March 21 memorandum was released Tuesday, ahead of the FDA advisory panel meeting.

Since pulling Vioxx from the market, Merck has faced more than 10,000 lawsuits from former patients and their families.

More information

For more information on heart disease and cox-2 inhibitors, visit the American Heart Association Association.

SOURCES: April 12, 2007, U.S. Food and Drug Administration teleconference with Robert Meyer, M.D., M.P.H., director, Office of Evaluation II, Center for Drug Evaluation and Research; Bob Rappaport, M.D., director, Office of Drug Evaluation II, Division of Anesthesia, Analgesia and Rheumatology Products, and John Jinkins, MD, director new drugs; Eric J. Topol, M.D., director, Scripps Translational Science Institute, La Jolla, Calif.; April 12, 2007, press statement, Public Citizen; Associated Press
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