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Fresh doubts over rosiglitazone

A new Cochrane systematic review has cast further doubt on the safety profile of rosiglitazone, and called for the system of drug approval to be overhauled.

Pooled data from the new analysis, which was of 18 trials including more than 8,000 participants, found patients taking rosiglitazone gained up to 11lb in weight and were at a doubled risk of oedema.

The largest single trial, which looked at more than 4,000 patients, uncovered evidence of raised cardiovascular risk and increased numbers of broken and fractured bones in women. The Cochrane review follows a well-publicised meta-analysis in the New England Journal of Medicine, which found rosiglitazone raised the risk of heart attacks.

Lead reviewer Dr Bern Richterm, a researcher at Heinrich-Heine university in Düsseldorf, Germany, said: 'The benefit-to-risk ratio of rosiglitazone therapy in type 2 diabetes is in urgent need of clarification. This new safety data should lead to a very cautious approach to rosiglitazone use. If possible, other drugs should be used.

'He added that 'even a tiny risk associated with a drug such as rosiglitazone, prescribed to millions of people, will eventually translate into grave consequences'.

Dr Martin Hadley-Brown, a GP in Thetford, Norfolk, and chair of the Primary Care Diabetes Society, said: 'I think in time we will see more and more doctors giving pioglitazone [as an alternative to rosaglitazone]. It's a disappointment that rosaglitazone is not as good as we thought.'

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