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FDA Advisory Panel Rejects Vioxx Successor
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Page: << Prev | 1 | 2 | 3 "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.
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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.
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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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