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FDA Advisory Panel Rejects Vioxx Successor
Merck's new painkiller Arcoxia shows cardiac risk, committee says in 20-1 vote.
By Steven Reinberg
HealthDay Reporter
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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.
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"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]."
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Copyright © 2007 ScoutNews, LLC. All rights reserved.
Last updated 4/12/2007
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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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