New research has suggested a link between a common drug used to treat Type 2 diabetes and the risk of heart attacks. The Irish Medicines Board said that it would be consulting an EU expert group to assess the information.
A study in the New England Journal Of Medicinefound a link between rosiglitazone (Avandia) and a 43 per cent increased risk of heart attacks. It also claimed that the drug increases the risk of heart death by 64 per cent.
The US Food and Drug Administration (FDA) issued a safety alert in relation to the drug yesterday but said that it was not asking GlaxoSmithKline, the drug's manufacturer, to take any specific action at this time. Analysis of all available data, some with conflicting results, in relation to the drug was ongoing, it said.
The Irish Medicines Board, which is responsible for licensing drugs on the Irish market, said it was aware of the study and that it would be discussed at an EU scientific committee meeting in London later this week, where the IMB would be represented. "The IMB will await the outcome of discussions at that meeting," a spokeswoman said.
The drug has been on the market for a number of years and the Diabetes Federation of Ireland said that it was commonly used here. Anna Clarke, health promotion and research manager with the federation, said that there were about 150,000 people in the State with Type 2 diabetes, and anyone with the condition was at increased risk of heart disease, which had to be borne in mind.
She said that the study warranted further investigation but pointed out that the drug was only used under very strict medical supervision. People on the drug, she said, should continue taking it but attend for their regular check-ups.
GSK said that it "strongly disagreed" with the findings. "GSK stands firmly behind the safety of Avandia when used appropriately, and we believe its significant benefits continue to outweigh any treatment risks," it said in a statement.
Shares in the company fell when news of the study broke.
The study involved analysing published literature, the website of the FDA and a clinical-trials registry maintained by GSK. Of 116 potentially relevant studies, 42 trials were included in the analysis. Its authors acknowledged that the study was limited by a lack of access to original data.
"Despite these limitations, patients and providers should consider the potential for serious adverse cardiovascular effects of treatment with rosiglitazone for Type 2 diabetes," they said.