FDA needs more sophisticated approach to drug safety

doi:10.1136/bmj.330.7501.1166-b

BMJ 2005;330:1166 (21 May), doi:10.1136/bmj.330.7501.1166-b

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FDA needs more sophisticated approach to drug safety

Bryan Christie

Edinburgh

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

A much more sophisticated approach is needed on drug safetyif the recent debacle concerning rofecoxib (Vioxx) is not tobe repeated. This is the view of one of the doctors who firstraised fears about the cyclo-oxygenase-2 (COX 2) inhibitor.

Dr Garret FitzGerald, director of the Institute for TranslationalMedicine and Therapeutics at the University of Pennsylvania,told a conference in Edinburgh that the problems surroundingrofecoxib could well happen again in a different guise. He blamedthe problem on the "absence of science" and the failure to acton emerging evidence of risk.

Rofecoxib was withdrawn by Merck in September when the companyacknowledged that the drug carried "serious cardiovascular risks"( BMJ 2004;329: 816[Free Full Text]).

Dr FitzGerald told the conference, organised by the Royal Collegeof Physicians of Edinburgh, that his team was reporting plausiblebiological evidence of a cardiovascular risk as early as . . . [Full text of this article]

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