Call to ‘suspend’ diabetes drug. More than 100,000 patients in the UK use Avandia drugs
By Nick Triggle Health reporter, BBC News, 23 September 2010
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. It should not take this long to come to a decision when there is evidence that people’s lives may be at risk.”
But the recommendation in Europe contrasts with the US where regulators have decided only to introduce tougher restrictions over its use – a verdict which they confirmed at the same time as the EMA announcement.
Avandia was originally licensed with warnings about the risks for patients with heart failure. These were later expanded to include other heart problems after further research into its use.
The advice by an expert panel of advisers, who looked at the issue amid mounting concerns, will now be passed to the European Commission. It may be several months before they make a final ruling, although it is unusual for them to ignore advice from the regulator.
Dr Ellen Strahlman, chief medical officer at GlaxoSmithKline, the manufacturer, said: “Our primary concern continues to be patients with type 2 diabetes and we are making every effort to ensure that physicians in Europe and the US have all the information they need to help them understand how these regulatory decisions affect them and their patients.”
GSK said it still believes the drug was an “important treatment” for diabetes patients.
Peter Walsh, head of the patient group Action Against Medical Accidents, said: “Medical experts have been warning for months about the dangers of this drug, which have been well documented.”
“It should not take this long to come to a decision when there is evidence that people’s lives may be at risk. We need a review of how medicines are regulated in the UK and Europe as a whole. We fear that pharmaceutical companies have far more influence than they should have.”
Dr. Pinna says:
Glaxo has a powerful sales team. The sole purpose of Glaxo is to make a big profit, no matter how many lives are lost.
When Avandia first came out, I was “pushed” to use it. I never did.Â I read the medical literature, and I saw that this drug would be harmful to the heart and liver.
Now, the Europeans have thrown it out. That says something is wrong with the American FDA. It says that the FDA has more unscrupulous employees than the Europeans.
What this drug company is doing is criminal. They know they are killing people. Hopefully, such criminality will be paid for with jail time in the future.