A drug taken by thousands of men and women with diabetes could be banned over concerns that it raises the risk of heart disease.
The safety of Avandia – currently prescribed to 100,000 people in Britain – is under investigation by the Europeans Medicine Agency, a watchdog with the power to withdraw treatments in Britain.
It follows research that shows the drug puts users at a 60 per cent greater risk of heart failure than other medication.
Avandia is currently prescribed to people with type 2 diabetes, the form of the disease linked to obesity which usually occurs in middle age.
It is already being investigated in the US by the Food and Drugs Administration, the medicines watchdog, who will report their findings next week.
Last year, GSK published the results of the study, which it said showed Avandia was not associated with an increase in cardiovascular hospitalisation or cardiovascular death compared with patients receiving two other commonly-used diabetes drugs.
But Dr Marciniak said Record was “inadequately designed and conducted to provide any reassurance about the cardiovascular safety of the drug”. “We cannot rely upon Record to provide reassurances regarding the effects of rosiglitazone upon cardiovascular risk,” he said, using the drug’s generic name.
However, GSK responded that the FDA briefing document in its entirety said the overall conclusion was that the data from Record was robust and reliable, adding that “the conduct of the study was done to good clinical practice standards”.
Britain’s biggest drug company said a comprehensive review submitted to the panel showed Avandia was safe, adding: “Since 2007 we have seen results from six controlled clinical trials looking at the cardiovascular safety of Avandia. Together they show that this medicine does not increase the overall risk of heart attack or stroke.