What's Left of the FDA After Vioxx?
By Edward J. Parr Jr., Esq.
May 9, 2005
In the end, the FDA decided to do nothing about Vioxx (unless and until Merck proposes to recommence marketing), to take Bextra off the market, and to re-label Celebrex and many other NSAIDs. In their April 6, 2005, memorandum entitled "Analysis and recommendations for Agency action regarding non-steroidal anti-inflammatory drugs and cardiovascular risk," FDA officials concluded:
The three approved COX-2 selective NSAIDs (i.e., celecoxib, rofecoxib, and valdecoxib) are associated with an increased risk of serious adverse CV events compared to placebo. The available data do not permit a rank ordering of these drugs with regard to CV risk. ...
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