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Published on 6 September 2010

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Drug withdrawal advice unheeded

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A recommendation from the British Medical Journal (BMJ) to withdraw a popular diabetes drug has gone unheeded for two months despite concerns the drug may raise the risk of heart attacks, it has been revealed.

The safety body called for rosiglitazone, marketed as Avandia, to be withdrawn immediately and said it should never have been licensed.

An expert committee of the Medicines and Healthcare products Regulatory Agency (MHRA) was advised to withdraw the drug by the Commission on Human Medicines in July because the “risks of rosiglitazone outweigh its benefits”, an investigation found. The drug “no longer has a place on the UK market”, it said.

The European Medicines Agency (EMA) approved rosiglitazone, which is manufactured by Glaxo SmithKline (GSK), in 2000 to help lower blood sugar levels in patients who have type 2 diabetes.

GSK said their “extensive research” showed the drug was “safe and effective when it is prescribed appropriately”.

But since its approval, several studies have suggested the drug may lead to a small overall increase in the risk of heart attacks and the BMJ’s investigations editor, Dr Deborah Cohen, said the European approval process was not rigorous enough.

She also raised concerns about the quality of the data used by GSK, the lack of publicly available trial results for independent scientific scrutiny, and failures to act swiftly on emerging safety fears.

The journal said doctors were advising that no new patients should start taking the drug and patients already using rosiglitazone should review their options. Those at higher risk of heart disease should be advised to stop taking it.

BBC One’s Panorama: A Risk Worth Taking? is to be broadcast on Monday at 8.30pm.

Copyright Press Association 2010

British Medical Journal



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