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A correction has been published: N Engl J Med 2005;352(11):1163.

Correspondence
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Volume 351:2875-2878 December 30, 2004 Number 27
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Rofecoxib, Merck, and the FDA

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 by Topol, E. J.
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 by FitzGerald, G. A.
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To the Editor: Merck has been proactive and conscientious in evaluating the cardiovascular profile of rofecoxib (Vioxx); Dr. Topol's remarks to the contrary in his Perspective article (Oct. 21 issue)1 are false. First, his description of the time line obfuscates the facts. The Food and Drug Administration (FDA) approved Vioxx in May 1999. The clinical data then existing on 5435 patients who had been treated for up to 22 months did not suggest an adverse cardiovascular effect.2 Nevertheless, because the literature suggested a hypothetical possibility of both cardioprotective and prothrombotic effects of cyclooxygenase-2 (COX-2) inhibitors,1 Merck initiated adjudication of cardiovascular . . . [Full Text of this Article]


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