Dabigatran: How Safe?

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Within 12 weeks of marketing approval, dabigatran was found to be responsible for more adverse events than nearly all other medications.

Dabigatran is an oral direct thrombin inhibitor that is approved for the prevention of stroke in patients with atrial fibrillation (JW Oncol Hematol Oct 6 2009). It is administered in a fixed dose (150 mg twice daily) and does not require monitoring, which are advantages over warfarin. However, recent data suggest that, compared with warfarin, dabigatran might be associated with more frequent serious adverse effects.

Now, an editorialist has reviewed reports of serious or fatal bleeding associated with dabigatran and found that, during the first 6 months of availability, the drug was responsible for 505 adverse events due to hemorrhage (including 65 deaths), compared with only 176 for warfarin. Some of these events were in patients who received the drug off label (for postoperative thromboprophylaxis) or with amiodarone (which potentiates its actions) or tissue plasminogen activator (which alters hemostasis). Nevertheless, within 12 weeks of initial marketing approval, dabigatran was reported to be responsible for more adverse events than 98.7% of all other medications.

Comment: The high number of adverse events with dabigatran might be due to several factors: lack of familiarity with the mechanism of action of the drug, administration of a dose that is too high for some patients (i.e., the elderly or those with comorbidities), treatment of conditions other than those that led to its approval, and lack of a readily available reversing agent. As with any new drug, physicians should carefully review prescribing information, closely monitor the patient, and be aware of possible adverse effects.

David Green, MD, PhD

Published in Journal Watch Oncology and Hematology July 31, 2012

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