Vioxx risks known since 2000

Vioxx heart risks apparent for years

12:16 05 November 04

NewScientist.com news service

Scientific evidence of increased heart attack risk associated with popular arthritis drug Vioxx was available as early as 2000, say Swiss scientists, although the drug was only withdrawn in September 2004.

Merck & Co, Inc, pulled its product from the market on 30 September after participants in a clinical trial of Vioxx’s effects on colon cancer started to show increased risk of heart attack.

But after analysing the results from 18 randomised clinical trials and 11 observational studies - many completed before 2001 - Peter Juni at the University of Berne, Switzerland, and his colleagues believe that the decision could have been made much earlier.

“If we can do this kind of analysis, it’s difficult to see why it wasn’t done by the drug company or the licensing authorities years ago,” says co-author Matthias Egger.

By the time it was withdrawn, an estimated 80 million people worldwide had taken Vioxx (rofecoxib). A memo posted by the US Food and Drug Administration (FDA) on its website on 2 November 2004 suggests that Vioxx may have contributed to almost 28,000 heart attacks in the US between 1999 and 2003.

But Merck dismissed the validity of the new study, published on Friday, saying Merck had been “vigilant in monitoring and disclosing the cardiovascular safety of Vioxx and that the company absolutely disagrees with any implication to the contrary”. A scientific critique, published by Merck in response, questions the methodology of the new study.

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