He pointed out that overall, the three novel oral anticoagulants – dabigatran and the factor Xa inhibitors, apixaban and rivaroxaban – approved for the nonvalvular AF indication, appear to reduce the risk of stroke and death, “and across the board, they all show significantly less intracranial hemorrhage.”
“The availability of agents that have a lower intracranial hemorrhage risk, such as dabigatran, really is an advantage and will hopefully lead to more patients with atrial fibrillation being appropriately treated, instead of being undertreated because of fear of bleeding into the brain,” he said.
The FDA plans to publish the Medicare study and will continue to review the risks of bleeding with anticoagulants.
Dabigatran is now also approved for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for 5-10 days, and to reduce the risk of recurrence of DVT and PE in patients who have been previously treated.
The FDA has issued two previous safety alerts regarding the bleeding risks associated with dabigatran, in 2011 and 2012.
Dr. Kaul is a consultant to Boehringer Ingelheim and has equity interest in Johnson and Johnson. Dr. Bhatt said he has research grants with Amarin, AstraZeneca, Bristol-Myers Squibb, Eisai, Ethicon, Medtronic, Roche, Sanofi Aventis, and the Medicines Company. He is also on the executive committee for the RE-DUAL PCI trial, a large study comparing dabigatran to warfarin in stented patients with AF, which will be starting soon.
The FDA notice is available here. Serious adverse events associated with dabigatran and warfarin should be reported to the FDA at 800-332-1088 or at MedWatch.