The authors emphasize the critical need for a rapid reversal agent for dabigatran in cases of life-threatening hemorrhage, particularly in frail elderly patients.
In response to Eikelboom and Weitz: when prescribing a drug with side effects that include life-threatening hemorrhage, reversal is not "desirable," it is essential.Our letter to the Editor never mentioned prothrombin complex concentrates.Rapid reversal is indeed associated with reduced morbidity and mortality. 1]3 Thromboelastography detects the effects of dabigatran within minutes (and the values for activated clotting time were markedly prolonged in all the patients described in our letter).Partialthromboplastin times were normal.The dilutethrombin-time assay with dabigatran calibrators is currently labeled for research use only.Eikelboom and Weitz state the deaths could not be attributed to "lack of an antidote."These patients were receiving dabigatran and presented with coagulopathy, and the multidisciplinary team caring for them could not control their hemorrhages.Next, although an absolute reduction of 0.2 percentage points in intracranial hemorrhage may be statistically significant (in 18,000 patients), this may not be clinically meaningful. 4 Finally, they state that a lack of an antidote should not deter physicians from prescribing dabigatran.We hope all prescribers will take note of the Food and Drug Administration alert re-garding dabigatran and, in doing so, expand the risk-benefit conversation with their patients. 5
Harper et al. (2012) studied this question.