BMJ  2005;330:862 (16 April), doi:10.1136/bmj.330.7496.862-a

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Pfizer is asked to suspend sales of painkiller

Jeanne Lenzer

New York

The first 150 words of the full text of this article appear below.

In a move that took experts by surprise, regulatory agencies in the United States and Europe have asked the drug maker Pfizer to suspend sales of its cyclooxygenase-2 (COX 2) inhibitor valdecoxib (Bextra).

The US Food and Drug Administration's move comes less than two months after an advisory panel recommended to the FDA that the drug remain on the market ( BMJ 2005;330: 440, 26 Feb[Free Full Text]).

Pfizer said it "respectfully disagreed" with the regulators' assessments of the risk-benefit ratio of the drug but agreed to "voluntarily" suspend sales.

Although the suspension of valdecoxib was welcomed by many experts, the decision by the FDA to go further than the European Medicines Agency by ordering "black box" warnings on all non-steroidal anti-inflammatory drugs drew criticism from a number of experts.

"To lump everything within a black box dilutes the message about COX 2s and sows confusion among . . . [Full text of this article]


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FDA advisers warn: COX 2 inhibitors increase risk of heart attack and stroke
Jeanne Lenzer
BMJ 2005 330: 440. [Extract] [Full Text] [PDF]

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