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Pradaxa bleeding risk seems within standard: FDA

(Reuters) – The risk of serious bleeding among new users of Pradaxa appeared to be no higher than in patients on warfarin, U.S. regulators said.

The announcement Friday by the U.S. Food and Drug Administration may allay some safety concerns about Pradaxa, a pill developed by the privately held drugmaker Boehringer Ingelheim, to prevent strokes among patients with atrial fibrillation.

The regulator’s findings were based on an assessment of insurance claims and other data.

Over the past year, the FDA has been analyzing reports of serious bleeding among patients prescribed Pradaxa, including gastrointestinal bleeding and bleeding in the brain.

The agency said on Friday a comparable risk of serious bleeding for Pradaxa and warfarin was suggested by its review of insurance claims and by analyzing electronic healthcare data from multiple other sources.

The FDA said it was also planning other assessments of Pradaxa’s bleeding risks.

The medicine competes with Xarelto, a stroke-prevention pill for atrial fibrillation patients developed by Johnson & Johnson and Bayer AG.

A similar pill being developed by Bristol-Myers Squibb and Pfizer Inc, Eliquis, is awaiting U.S. approval.