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Bextra not available in Australia

Friday April 8, 2005

Pfizer Australia says that a painkiller voluntarily suspended in the US market is NOT available in Australia.

The FDA informed Pfizer in the US overnight that, in the agency’s view, Bextra’s cardiovascular risk could not be differentiated from other NSAIDs and there is a lack of any demonstrated advantages for Bextra compared with other NSAIDs. However, the agency has concluded that the additional, increased risk of rare but serious skin reactions associated with Bextra, already described in its label, warranted its withdrawal from the market.

Pfizer respectfully disagrees with the FDA’s position regarding the overall risk/ benefit of Bextra. The company has agreed to voluntarily suspend sales of the medicine pending further discussions with the FDA.