Safety of dabigatran

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Increasing concerns have been raised about the safety of the orally active direct thrombin inhibitor dabigatran. The US FDA and the European Medicines Agency are evaluating post-marketing reports of 256 serious bleeding events leading to death in patients taking dabigatran.

The median age of those with reported bleeding events in 2011 was 80 years, raising a question of safe dosing in older patients, who may also have reduced renal function and other co-morbidities.

A meta-analysis of seven randomized trials indicated that use of dabigatran for a variety of indications (atrial fibrillation, acute coronary syndrome, venous thromboembolism treatment or prophylaxis), when compared with warfarin, enoxaparin, or placebo controls, was associated with a significantly higher risk of myocardial infarction or acute coronary syndrome (Arch Intern Med 2012;172:397).

There is a safety concern of dabigatran in trauma patients, older patients, and those with renal disease (N Engl J Med 2011;365:2039) (UptoDate)