The FDA's Critique of the Anturane Reinfarction Trial

Abstract

The Food and Drug Administration recently refused to approve a claim that sulfinpyrazone (Anturane) was effective in the prevention of sudden death during the first six months after myocardial infarction. The Ciba—Geigy company based this claim entirely on the results of a controlled multicenter trial, the Anturane Reinfarction Trial, which was reported and discussed in the Journal.^{1 2 3}—⁴ This paper summarizes the problems with the trial that were identified during FDA staff review and the reasons for the FDA decision.We are aware that it is unusual for an FDA critique of a clinical trial to be published in the medical . . .