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US safety alert over rosiglitazone

The US Food and Drug Administration has issued a safety alert over a glitazone after a meta-analysis suggested it increased cardiovascular risks.

The researchers, whose study was published online by the New England Journal of Medicine, said the findings raised 'serious concerns' over rosiglitazone's safety.

The analysis of 42 trials, led by the head of one of the world's leading cardiovascular organisations, found rosiglitazone raised the risk of myocardial infarction by 43% and risk of death from all cardiovascular causes by 64%.

Dr Steven Nissen, leader of the analysis and president of the American College of Cardiology, US, said: 'The results raise serious concerns about the cardiovascular safety of rosiglitazone.'

Dr Nissen, who is also chair of the department of cardiovascular medicine at the Cleveland Clinic, added: 'The effect of anti-diabetic therapy on cardiovascular outcomes is of critical importance as cardiovascular disease is the overwhelming source of diabetic mortality. Unfortunately, rosiglitazone appears to increase, rather than decrease, the most serious complication of diabetes – heart disease.'

The drug's manufacturer, GlaxoSmithKline, has rejected the findings saying the paper was 'based on incomplete evidence and a methodology that the author admits has significant limitations'.

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