Diabetes drug 'poses heart risk and must be withdrawn'
Published 06/09/2010 | 05:00
ONE OF the world's biggest-selling drugs for diabetes should never have been licensed and should now be withdrawn, according to a leading research journal.
The British Medical Journal (BMJ) said its concerns about the drug Avandia, which has been linked to heart attacks, were too great to allow its continued use.
The drug is made by multinational giant GlaxoSmithKline (GSK), which employs 1,400 people in Ireland, and is also the subject of an Irish Medicines Board review here.
During the past decade, Avandia has been manufactured, among other drugs, by GSK in its plant in Currabinny, Carrigaline, Co Cork.
The BMJ claims the UK drug regulator was advised by the Commission on Human Medicines to withdraw the drug last July. The advice from the commission said the "risks of rosiglitazone outweigh its benefits and it no longer has a place on the UK market".
But the BMJ said that it remained 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.
Fiona Godlee, editor-in-chief of the BMJ, said the drug "should not have been licensed and should now be withdrawn".
Last night, it emerged the Irish Medicines Board (IMB) was also involved in a review of the drug. It is expected this review will be finished later this month. Health care professionals have been written to by the IMB, informing them of the review.
Avandia is also the subject of a BBC 'Panorama' programme, to be broadcast tonight, which is expected to raise similar concerns about the drug.
GSK disputes the BMJ's allegations. It has previously maintained its trials were conducted responsibly and that the drug is safe when administered correctly.
When Avandia was lauched in 2000, the drug was hailed as a turning point in the treatment of diabetes. Sales soared until 2007 when a review in the New England Journal of Medicine showed a significant increase in the risk of heart attack associated with the drug.
The BMJ investigation, based on documents obtained under the Freedom of Information Act, concluded there was a "paucity of evidence" during the European approval process a decade ago, and some experts involved in the process were concerned about long-term risks and benefits.
The report also raises concerns about the quality of the data used by GSK to show that rosiglitazone did not lead to increased heart problems compared to other diabetes drugs.
GSK said: "GSK has carried out an extensive research programme involving more than 50,000 patients to analyse the safety and benefits of rosiglitazone. No other diabetes medicine introduced in the past 10 years has such an extensive safety database. We reject any suggestion that there is a lack of publicly available trial results related to rosiglitazone for independent scientific scrutiny." (© Independent News Service)