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Date Submitted:
12/12/07
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FDA Advisory Panel Rejects Vioxx Successor
Description:
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 Read the Complete Article Similar content: FDA Says No to Vioxx Successor, in Arthritis FDA Panel Backs Prostate Cancer Vaccine, in Prostate Cancer Vioxx Ban Tied to Rise in Serious GI Trouble , in Arthritis Vioxx Safer on Lower Digestive Tract, Too, in Arthritis Vioxx Settlement Puts Painkillers Back in the Spotlight, in Arthritis |
