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Stroke and Heart Attack: A Class Effect of COX 2 Inhibitors?
Henry I. Bussey, Pharm.D.
October 2004
Two leading authorities suggest that the increased risk of heart attack and stroke that resulted in the withdrawal of rofecoxib (Vioxx) is a class effect of the COX 2 inhibitors. Dr. Garret A. FitzGerald reviewed the available clinical data and explained how COX2 inhibitor-induced alterations in prostaglandin I-2 and thromboxane, together with potentiation of atherosclerosis, can lead to an increased risk of heart attack and stroke. Dr. Eric J. Topol offers additional comments supporting Dr. FitzGerald's position and significantly criticizes both the FDA and Merck for their delay in adequately addressing this risk. He further calls for a Congressional investigation into the role of the FDA and Merck in their handling of the available information.
References
1. FitzGerald, GA. Coxibs and Cardiovascular Disease. N Engl J Med. 351;17: 1709-11.
2. Topol EJ. Failing the Public Health — Rofecoxib, Merck, and the FDA. N Engl J Med. 351;17: 1707-09.
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