Canadian health officials have added new label warnings to a popular blood thinner, indicating the risk of bleeding events may be increased among individuals with kidney problems.
Health Canada announced on March 16, 2012 that the label for Pradax (dabigatran etexilate) would be updated to include new information regarding its use in kidney patients and those with severe valvular disease or prosthetic heart valves.
Pradax, an oral anticoagulant, is authorized in Canada for the prevention of stroke and systemic embolism in patients with atrial fibrillation. Pradax is sold under the name Pradaxa in the U.S. It is a relatively new blood thinner, which was introduced by Boehringer Ingelheim as a superior alternative to Coumadin (warfarin). It was approved by the U.S. Food & Drug Administration (FDA) in October 2010.
However, in recent months, concerns have been mounting about potentially dangerous Pradaxa bleeding side effects. Unlike the bleeding that occurs with warfarin – which can be stopped via the administration of vitamin K – there is no antidote for Pradaxa bleeding.
The new warnings in Canada come as concerns about the risk of serious and potentially fatal bleeding events from Pradaxa increases among the medical community in the United States and several other countries. Since the medication was introduced in the U.S., hundreds of deaths have been reported among Pradaxa users who experienced internal bleeding or hemorrhages that doctors were unable to stop.