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The Government's drug safety watchdog is to investigate new US data suggesting valdecoxib (Bextra) could be associated with an even greater risk of cardiovascular disease than rofecoxib.

Patients taking the drug were at double the normal risk of heart attacks or strokes, according to a meta-analysis of 12 trials presented at the American Heart Association conference earlier this month.

Researchers analysed 5,930 patients and found the overall relative risk was 2.19 for patients taking valdecoxib ­ and 1.77 for those prescribed the drug for arthritis.

The Medicines and Healthcare Products Regulatory Agency said the Committee on Safety of Medicines would be reviewing all new information as it came in, including results presented at conferences, and would not wait for peer-reviewed publication.

It also emerged that the expert who presented the data had been forced to step down from the US Food and Drug Administration advisory panel on cox-2s because of conflict of interest over the research.

Speaking at the conference, Professor Curt Furberg, professor of public health sciences at Wake Forest University, said: 'Our analysis shows the cloud over the cox-2 inhibitors is getting darker.'

Fellow researcher Professor Garret Fitzgerald, professor of cardiovascular medicine at the University of Pennsylvania, suggested the 'magnitude of the signal was even greater than with rofecoxib'. But he admitted the study was not 'gold standard'.

GPs expressed concern at the uncertainty over cox-2s, but cautioned against jumping to conclusions. Dr Graham Davenport, president of the Primary Care Rheumatology Society and a GP in Wrenbury, Cheshire, said: 'We must proceed with caution and avoid routinely prescribing anti-inflammatories to anyone with a heart problem.' But he said most rheumatologists did not feel there was a class effect.

Pfizer said data in the analysis came from a paper in the American Journal of Therapeutics that found no significant increase in thrombotic events in arthritis patients on valdecoxib.

By Rob Finch

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