Dabigatran Under the FDA's Watchful Eye

January 06, 2014

BETHESDA, MD — The US Food and Drug Administration is requesting input from the public on a proposed study that will assess safety outcomes in adults with atrial fibrillation who recently started treatment with dabigatran etexilate (Pradaxa, Boehringer Ingelheim) or warfarin[1].

Of particular concern with the one-time safety assessment is the risk of ischemic stroke, intracranial hemorrhage, and major extracranial hemorrhage in patients taking dabigatran when compared with warfarin-treated patients.

The workgroup designing the protocol for assessing dabigatran, led by Dr Alan Go (Kaiser Permanente Northern California, Oakland), states there are remaining questions "about the outcomes associated with dabigatran outside of the clinical-trial setting and in special populations."

For this reason, they plan to use data from the FDA Mini-Sentinel Distributed Database (MSDD) to "assess systematically the rates of bleeding and thromboembolic outcomes associated with the use of dabigatran and warfarin for patients with atrial fibrillation."

The MSDD includes data from nearly 100 million patients, and investigators plan to conduct a new-user parallel-cohort design study in adults 21 years or older diagnosed with nonvalvular atrial fibrillation. The request for public input was posted December 30, 2013 and closes on January 13, 2014. To submit comments on the proposed protocol, clinicians and researchers can access the MSDD here.

In a statement, Boehringer Ingelheim emphasizes that the proposed protocol does not mean there is a safety issue with dabigatran. In requesting public comment, the FDA emphasizes the same, that the proposed MSDD does not currently mean the anticoagulant is unsafe. According to Boehringer Ingelheim, previous assessments from the MSDD project were conducted in November 2012 and April 2013, and these found the risk of bleeding with dabigatran was not higher than those with new warfarin use. "To date, the FDA has not changed its recommendation regarding the use of [dabigatran] in the population for which it is approved," writes the company.

Dabigatran was approved in Europe in 2008 and in 2010 in the US. In addition to the potential bleeding risks with the new anticoagulant, observational studies and a meta-analysis have linked the drug to an increased risk of MI. Other experts, however, have argued that the observed MI risk was simply the play of chance.

The FDA's request for public comment on dabigatran was first reported by Cardiobrief.

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