Celebrex to stay on the Market

"We need to find the unique patients that will benefit from this drug and work out what they need to be told," said meeting Chairman Alistair J.J. Wood of Vanderbilt University Medical School.


The committees were asked to assess the drugs after Merck & Co. pulled Vioxx from the market last fall because of health concerns. Since then questions have been raised about Bextra and Celebrex, both made by Pfizer Inc.


Yahoo! News - FDA Panel: Celebrex Should Stay on Market

BioBOOM Op/Ed: Looks like a big black box warning label will be the answer.... just like the marlboro man. A cynical view would be that the hearings were designed to mimimize litigation and damages from class action. All comes down, as most things, to Risk - Reward assessment but it would be nice to get some kind of responder measuring tool to screen prior and monitor patients. Some day we hope. If all drugs have risk and all drugs have benefits maybe approval should have a committment that the submitting company will also fund some kind of monitoring tools besides asking a pill popper if they have symptoms and slapping a warning label in fly speck font on the bottles.

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