Concerns about a lack of specific antidotes for new anticoagulants has existed for some time, despite the benefits they may bring in other aspects of care. An important piece of correspondence in the New England Journal of Medicine notes the potential for patient harm from a move from warfarin to the newer dabigatran:
Enthusiasm for this agent [dabigatran], however, must be tempered by three notable concerns: there is no readily available means for assessing the degree of anticoagulation with dabigatran, there is no readily available reversal strategy, and life-threatening bleeding complications can occur after an injury in patients taking this drug.
Lack of a readily available method to determine the degree of anticoagulation creates a major challenge to those treating injured patients. Moreover, the irreversible coagulopathy of dabigatran is of great concern to trauma and emergency physicians. Currently, the only reversal option for dabigatran is emergency dialysis (as suggested in a single line in the package insert). The ability to perform rapid dialysis in patients with bleeding whose condition is unstable or in those with large intracranial hemorrhages will present an incredible challenge, even at level 1 trauma centers.
The authors note that they have had several patients attend their hospital with trauma, and “that hemorrhagic complications and death resulting from trauma be included as part of the routine surveillance of all newly approved oral anticoagulants.”
In the UK haemorrhagic complications and death from trauma associated with newer anti-coagulants should be reported via the Yellow Card scheme. Please do so.
UPDATE: 8th December 2011
The FDA has initiated a Safety Review of dabigatran.