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
September 6th, 2010 at 10:33 pm
A diabetes drug taken by up to 100,000 patients increases the risk of heart attacks and should be withdrawn on safety grounds, senior doctors say today.
A report by the British Medical Journal says Avandia should never have been licensed in Britain because its risks outweigh its benefits.
One UK expert has calculated that the drug may cause as many as 1,000 extra heart attacks a year in Britain.
The warning – which raises concerns about the way drugs are tested and regulated – comes three months after the committee responsible for drug safety in the UK called for the drug to be withdrawn.
But despite it writing to GPs to alert them to the dangers, patients were not informed and tens of thousands of people are still taking the drug.
Experts stressed that patients should not stop taking medication without first seeing their doctor – but urged GPs to review the way they treated diabetes.
Avandia was approved by the European Medicines Agency in 2000 to help reduce blood sugar in patients with type 2 diabetes, the form that usually strikes in middle and old age.
http://www.dailymail.co.uk/health/article-1309340/Heart-attack-risk-diabetes-drug-Experts-Avandia-withdrawn.html
September 6th, 2010 at 11:55 pm
One of the world’s biggest-selling drugs for diabetes should never have been licensed and should now be withdrawn, says the British Medical Journal. It says its investigation into concerns about the drug, Avandia, made by British multinational GlaxoSmithKline, which has been linked with increased heart attacks, are too great to allow its continued use.
The BMJ claims that the UK drug regulator, the Medicines and Healthcare Products Regulatory Authority, was advised by the Commission on Human Medicines to withdraw the drug last July, but it remains on the market because the European Medicines Agency, which licenses drugs across Europe, has yet to reach a decision on Avandia, whose chemical name is rosiglitazone. The advice from the Commission said the “risks of rosiglitazone outweigh its benefits and it no longer has a place on the UK market”.
Fiona Godlee, editor-in-chief of the BMJ, said the drug “should not have been licensed and should now be withdrawn”. She called for “more robust regulatory processes and better access to the raw data used to license drugs to allow scrutiny by the scientific community”.
September 20th, 2010 at 2:54 pm
The U.S. Food and Drug Administration said on Friday its has begun a safety review of diabetes drug Actos after receiving early results from a long-term study designed to evaluate the risk of bladder cancer in people treated with the drug.
The early data showed an increased risk of bladder cancer in patients with the longest exposure to Actos and in those with the highest cumulative dose of the drug, the agency said in a statement.
The FDA said the preliminary results are based on 5-year data from an ongoing 10-year trial by the drug’s maker, Takeda Pharmaceutical Co Ltd.
Actos is in the same class of drugs as GlaxoSmithKline PLC’s Avandia, which has not been associated with bladder cancer but has been linked to heart risks.
The FDA said patients should not stop taking Actos unless told to do so by their doctor.
September 24th, 2010 at 3:48 pm
A widely-used diabetes drug should be pulled from the market, European regulators say.
Avandia is used to control blood sugar levels in type 2 diabetes patients.
It was licensed 10 years ago and more than 100,000 patients in the UK use it despite on-going concerns linking it to heart problems.
After reviewing safety data, the European Medicines Agency said the benefits no longer outweighed the risks and it should be suspended.
The drug – generic name rosiglitazone – is also used in combination with other drugs under the names Avandamet and Avaglim.
A spokeswoman for the regulator said: “Patients who are currently taking these medicines should make an appointment with their doctor to discuss suitable alternative treatments.
“Patients are advised not to stop their treatment without speaking to their doctor.”
http://www.bbc.co.uk/news/health-11397645
September 26th, 2010 at 12:15 am
Around 90,000 British diabetes patients were warned against continuing to use one of the most popular treatments for their condition after regulators ruled it could lead to heart attacks or strokes.
After a three-year battle with UK pharmaceutical giant GlaxoSmithKline, the European Medicines Agency (EMA) recommended that Avandia, or rosiglitazone, which is used by 2 million people worldwide, should no longer be used after growing concerns about its potentially damaging effects on patients. The benefits of the drug, which is used to control Type 2 diabetes, no longer outweighed its risks, the regulator ruled.
The decision means that no new prescriptions can be issued for it, and that no new patients can start receiving a drug once seen as a major breakthrough in tackling the disabling effects of diabetes.
Evidence linking Avandia to an increased risk of a heart attack or stroke has been building since 2007. GlaxoSmithKline has insisted that Avandia is safe but in July agreed to pay $460m(£304m) in damages to settle about 10,000 lawsuits in America linking its use to patients suffering serious medical setbacks.
http://www.guardian.co.uk/society/2010/sep/23/diabetes-drug-avandia-suspended-health-fears