FDA needs more sophisticated approach to drug safety

BMJ 2005; 330 doi: (Published 19 May 2005) Cite this as: BMJ 2005;330:1166
  1. Bryan Christie
  1. Edinburgh

    A much more sophisticated approach is needed on drug safety if the recent debacle concerning rofecoxib (Vioxx) is not to be repeated. This is the view of one of the doctors who first raised fears about the cyclo-oxygenase-2 (COX 2) inhibitor.

    Dr Garret FitzGerald, director of the Institute for Translational Medicine and Therapeutics at the University of Pennsylvania, told a conference in Edinburgh that the problems surrounding rofecoxib could well happen again in a different guise. He blamed the problem on …

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