Fears over serious bleeding risk associated with dabigatran as compared with warfarin can be tied to the increased awareness and vigilance and "stimulated reporting" involving a new drug, FDA officials concluded in a perspective published in the New England Journal of Medicine. Researchers said that in reviewing data from the FDA Adverse Event Reporting System, they found "no indication that dabigatran was not being used in accordance with its labeled directions." The review also did not find increased bleeding risk with dabigatran compared with warfarin.

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