GlaxoSmithKline, the drug firm that employs 1,600 people in Ireland, has been told by US researchers that its drug for treating diabetes, raises the risk of of risk of heart attack, though regulators have not yet taken any action on the widely used drug.
US regulators are reviewing the safety of the type 2 diabetes drug Avandia, but have not yet determined the significance of risks reported in a study released yesterday, a US Food and Drug Administration 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%.
However, 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.
The agency said it was not asking GlaxoSmithKline to take any action at the present time but would ask a public advisory committee to weigh in at a later date.
'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 2 diabetes,' the FDA said.
GlaxoSmithKline said it strongly disagreed with the study findings and believed Avandia's benefits outweighed its risks.
GlaxoSmithKline shares fell further today on fears for sales, profits and potential product liability claims over the diabates medicine.
Europe's largest pharmaceutical company closed down 1.4% to £13.62 in London, adding to a decline of 5% on Monday.
* US regulators say severe kidney failure and in some cases death have been reported in patients using Novartis's iron overload drug Exjade.
The Food & Drug Administration said patients using the drug, which removes excess iron from certain organs in patients receiving blood transfusions, also reported various blood deficiencies known as cytopenias that in some cases also led to death.
The agency added that Novartis has already included the new concerns on the drug's label. The company has also notified doctors.
