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.
Avandia
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.
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July 19th, 2010 at 7:45 pm
The drug Avandia is used by tens of thousands of British patients with type 2 diabetes – but how safe is it?
In the past few months, the manufacturer GlaxoSmithKline has paid out more than £330 million in compensation to U.S. patients for heart attacks, strokes and heart failure linked to the drug (also known by its generic name, rosiglitazone).
Such are the growing concerns that just last week a committee of the U.S. Food and Drug Administration conducted a two-day hearing into the drug’s side-effects.
A majority said they were worried it raised the risk of heart attacks.
However, opinion was so divided that they voted to leave the drug on the market but with more warnings on the label.
So where does this leave British patients? Some experts here are concerned many patients are still being prescribed the drug when there is a safer alternative.
In Britain, the drug is regulated by the European Medicines Agency, which has said it is going to conduct its own investigation later this week to see if Avandia should stay on the market. But for the past few years, the agency’s official response to concerns about the drug has been to say the benefits outweigh the risks.
Yet this view seems to be trailing some way behind the approach taken by diabetes experts and GPs.
‘We have had serious doubts about the safety of Avandia for a number of years,’ says Dr Ralf Abraham, of the London Diabetes and Lipid Centre.
‘We rarely prescribe Avandia because of the risks.
http://www.dailymail.co.uk/health/article-1296031/Should-taking-Avandia-As-diabetes-drug-linked-worrying-effects-experts-say-theres-safer-alternative.html
August 6th, 2010 at 11:40 am
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