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Cox-2's (and Pfizer?) on Slippery Slope
Posted: April 7, 2005The FDA has just hammered Pfizer's Bextra and Celerex as well as other NSAIDs (see "FDA Announces Series of Changes to the Class of Marketed Non-Steroidal Anti-Inflammatory Drugs (NSAIDs); FDA Press Release).FDA, which previously requested Pfizer to add a "black box warning" to Bextra's label (see "Bextra Label Updated with Boxed Warning Concerning Severe Skin Reactions and Warning Regarding Cardiovascular Risk"; FDA Talk Paper), now requests that Bextra be withdrawn from the market completely. FDA sad: "the overall risk versus benefit profile for the drug is unfavorable."
Is Celebrex -- and Pfizer along with it -- on a slippery slope towards serious market share loss or even withdrawal?