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Europe also needs agency for postmarketing surveillance

BMJ 2005; 330 doi: (Published 03 March 2005) Cite this as: BMJ 2005;330:540
  1. Silvio Garattini, director (
  1. Istituto di Ricerche Farmacologiche “Mario Negri,” Via Eritrea, 62, I-20157 Milan

    EDITOR—With respect to the withdrawal of rofecoxib (Vioxx), several months of debate on drug safety have focused on US policy, but very little has been said about the European situation.1 Some fundamental questions remain to be answered. For example, why did the manufacturer, and not the regulatory agencies, withdraw rofecoxib?

    Both the US Food and Drug …

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