Doctors continued to prescribe one of the world’s most popular drugs for the treatment of diabetes – despite having been warned two months ago that it can cause heart attacks.
The drug – also known as Rosiglitazone – was approved by the European Medicines Agency ten years ago to help lower blood sugar levels in patients with type two diabetes.
Its manufacturer – Glaxo SmithKline – says that “extensive research” involving more than 50,000 patients has shown the drug to be “safe and effective when it is prescribed appropriately”.
But now it has emerged that the Commission on Human Medicines advised the Medicines and Healthcare products Regulatory Agency (MHRA) in July that Avandia “no longer has a place on the UK market” and should be withdrawn, as its risks outweighed its benefits.
The Commission’s advice was been revealed following an investigation by the BMJ in collaboration with the BBC Panorama programme.
Dr Yoon Loke, a clinical pharmacologist based at the University of East Anglia, told Panorama that the drug could have caused an extra 1,000 heart attacks and aboutr 600 extra cases of heart failure in the UK last year.
“These are not acceptable risks in the long term and you scale up in the country, clearly that could lead to many hundreds of people being affected,” he said.
“But from day to day, the actual risk to a given patient is quite small.”
The BMJ’s investigations editor, Dr Deborah Cohen, said the European drug approval process was not rigorous enough and raised concerns about the quality of data used by Glaxo SmithKline.
The journal said that no new patients should start taking the drug, while those already taking it should consult their GP. It said that those at a higher risk of heart disease should be advised to stop taking it.
Avandia is one of theo world’s best-selling drugs, with global sales of more than £1.5bn. British doctors wrote out more than a million prescriptions for it last year, at a cost of around £30m.