, Volume 28, Issue 8, pp 651-658
Date: 20 Nov 2012

What are the Real Lessons from Vioxx®?

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In major medical journals, as well as in the public media, it has been said that regulators have not managed the risk issues of rofecoxib (Vioxx®)

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well. The Canadian Medical Association is even calling for a new body to be set up to monitor drug safety in that country. They are reported as saying that North America’s regulatory agencies have “failed miserably”.[1] In another article, the authors say: “our findings indicate that rofecoxib should have been withdrawn several years earlier. The reasons why manufacturer and drug licensing authorities did not continuously monitor and summarise the accumulating evidence need to be clarified”.[2] These are but two examples of the criticism of pharmacovigilance as it relates to rofecoxib and these reflect broader drug safety concerns.

In fact, pharmacovigilance detected the early signals of an increased risk of cardiovascular disorders with rofecoxi ...