FDA says reviewing risks of Glaxo diabetes drug

WASHINGTON (Reuters) - U.S. regulators are reviewing the safety of GlaxoSmithKline's Plc's diabetes drug Avandia but have not yet determined the significance of risks reported in a study released on Monday, a Food and Drug Administration official said.

A study published in the New England Journal of Medicine said Avandia increased cardiac-related deaths and heart attacks. Dr. Robert Meyer, head of the FDA office that reviews diabetes drugs, said other data contradicted those findings.

"FDA has not confirmed the clinical significance of the reported increased risk in the context of other studies," Meyer told reporters during a conference call.

"Further, the FDA does not know whether the other approved treatments in the same class of drugs ... have less, the same, or other greater such risks," he said.

The agency said it was not asking GlaxoSmithKline to take any action at the present time but would take the issue to a public advisory committee.

"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.