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FDA finds no extra bleeding risk from dabigatran

NEWS IN BRIEF — Posted Nov. 19, 2012

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The Food and Drug Administration affirmed in November that dabigatran, an anticoagulant marketed as Pradaxa by Boehringer Ingelheim, does not pose a higher bleeding risk for patients compared with those who start treatment with warfarin.

The FDA’s assessment of the postmarket safety of dabigatran, a blood thinner used to cut the stroke risk for patients with atrial fibrillation, was done by analyzing insurance and claims data for reports of gastrointestinal and intracranial hemorrhages. The investigation was started after the FDA “received a large number of postmarketing reports of bleeding among Pradaxa users,” according to the agency’s safety announcement (link).

The FDA said it will not change its recommendations regarding dabigatran as a result of the analysis. Tens of thousands of patients are hospitalized annually due to hemorrhaging caused by blood thinners and careful management of these medications should be a patient safety priority, said the Centers for Disease Control and Prevention.

Note: This item originally appeared at http://www.ama-assn.org/amednews/2012/11/19/prbf1119.htm.

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