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Jan 25, 2005

An arthritis drug axed on safety grounds probably killed thousands of patients, scientists said yesterday.

Researchers believed Vioxx may have caused up to140,000 serious heart problems in the US alone since its introduction in 1999.

And many of these cases were likely to have been fatal, they claimed.

Vioxx, which has the scientific name rofecoxib, was prescribed to 400,000 patients in the UK and belongs to a family of drugs known as Cox-2 inhibitors.

But it was taken off the market last year after a three-year trial linked it to an increased risk of heart trouble.

The study, published online by the Lancet medical journal, showed people given Vioxx had 34 per cent higher chance of heart disease when compared with patients taking other drugs.

US Drug Safety chief Dr David Graham said: 'Between 88,000140,000 excess cases of serious coronary heart disease probably occurred in the US over the market life of rofecoxib.

'The US national estimate of the fatal heart attack plus sudden cardiac death was 44 per cent, which suggests that many of the excess cases attributable to rofecoxib use were fatal.'

In an accompanying commentary, Simon Maxwell and David Webb of Edinburgh University said attention would now focus on the safety of other Cox-2 inhibitors.

Prof Webb said the lessons learned from Cox inhibitors underlined the need for full publication of all clinical trial data on newly licensed drugs.

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