US researchers have told GlaxoSmithKline that its drug for treating diabetes raises the risk of heart disease; however regulators have not yet taken any action on the widely-used drug.
GlaxoSmithKline employs 1,600 people in Ireland.
US regulators are reviewing the safety of the type two diabetes drug Avandia, but have not yet determined the significance of risks reported in a study released yesterday, a US Food and Drug Administration (FDA) official said.
A study published in the New England Journal of Medicine said Avandia increased the risk of cardiac-related deaths by 64% and heart attacks by 43%.
But Dr Robert Meyer, head of the FDA office that reviews diabetes drugs, said other data contradicted those findings and the FDA has not confirmed the clinical significance of the reported risk.
'Patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack should talk to their doctor about this new information as they evaluate the available treatment options for their type two diabetes,' the FDA said.
