[QODLink]
Europe
Diabetes drug comes under scrutiny
European drugs watchdog discusses safety of Avandia after British regulators raise concerns over heart risks.
Last Modified: 08 Sep 2010 16:22 GMT
The Food and Drug Administration in the US has placed Avandia under scrutiny since 2007  [EPA]

A European drugs watchdog is holding a special meeting to review the safety of Avandia, a widely-used diabetes drug, amid calls for it to be withdrawn because of concerns about heart risks.

The European Medicines Agency (EMA) met in London, the British capital, on Wednesday, two days after UK drug regulators called for product to be pulled from the market.

It said the extraordinary session was necessary because of the complexity of the data being assessed, but will not decide on the drug's future until its next scheduled meeting in late September.

The British Medical Journal (BMJ) and some leading doctors have criticised the response, calling for Avandia to be pulled off the market immediately - saying it should never have been licensed in the first place.

'Multiple problems'

On Monday, Britain's Medicines and Healthcare products Regulatory Agency (MHRA), said Avandia should be pulled from the UK market because of concerns that the drug could increase the risk of heart attacks.

They said an independent panel of experts had advised that the risks of the product outweighed its benefits, and that the drug should no longer be sold in Britain.

The body said it had sent a letter to doctors in July advising them to consider alternative treatments.

Avandia, made by pharmaceutical company Glaxo Smith Kline (GSK), was approved by the EMA in 2000 to help lower blood sugar levels in patients with Type 2 diabetes.

GSK has maintained that its extensive research involving over 50,000 patients has shown that Avandia does not increase the overall risk of heart attack, stroke or death compared to other diabetes drugs.

"We continue to believe that Avandia is safe and effective when it is prescribed appropriately," the company said in a statement.

But the British Medical Journal was critical of both GSK's research methods and the European approval process, outlining what were described as multiple problems associated with Avandia's safety in a report published on Monday.

In the US, the Food and Drug Administration (FDA) has placed Avandia under scrutiny since 2007, when a study suggested that patients taking the drug were 43 per cent more likely to experience a heart attack than those taking other diabetes drugs or no diabetes medication at all.

Source:
Agencies
Topics in this article
Country
City
Organisation
Featured on Al Jazeera
Murder of Somali draws ire of foreign African nationals over rising xenophobic violence.
We look at the impact of increased sanctions against the Islamic Republic and ask who it really affects.
Tupamaros enforce rough justice in Venezuela's slums to support socialism, but critics say the group are violent thugs.
More than a decade ago the US launched a war against Afghanistan, but was it a justified battle?
Featured
Two years since the start of the uprising, rebels and Assad's forces remain locked in conflict.
Extensive coverage of political unrest that spread from Istanbul to other areas.
Revelations over NSA spying are threatening president's European trip.
Some urbanites are returning to their rural roots to farm the land.
Kuwait's 'Bidoon' have been stripped of rights and treated as second-class citizens.
join our mailing list