The British Medical Journal's Editor- in-Chief Fiona Godlee has called for the withdrawal of GlaxoSmithKline Plc's diabetes drug, Avandia, saying that the drug should never have been licensed. GlaxoSmithKline has, however, rejected the claim.
An investigation by the journal revealed that in July the UK Commission on Human Medicines advised the country's drugs regulator, the Medicines and Healthcare Products Regulatory Agency, to withdraw the drug from the market. This was because the risks associated with the drug were seen to outweigh its benefits. Further, the investigation also found that members of a European panel, which had reviewed the drug prior to its EU-wide approval in 2000, had concerns about the long-term risks and benefits of Avandia, also known as rosiglitazone.
The journal has also raised concerns regarding the quality of the data GlaxoSmithKline uses to illustrate Avandia did not lead to increased heart problems as compared with other diabetes drugs.
Currently, the European Medicines Agency is reviewing the drug and will recommend whether or not it should stay on the market, later this month. The US Food and Drug Administration is also due to make a decision on the drug following a US advisory panel vote in July to keep it on the market but with additional warnings.
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