Call to 'suspend' diabetes drug

By Nick Triggle
Health reporter, BBC News

Image caption,
More than 100,000 patients in the UK use Avandia drugs

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."

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."

Simon O'Neill, of Diabetes UK, agreed action in such cases should be taken more quickly.

But he added: "Patient safety is paramount, so we welcome that a decision has been made about Avandia."

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