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EMA Updates Pradaxa Bleeding Guidance

Filed May 25th, 2012 Laurie

The European Medicines Agency says doctors and patients should be given clearer guidance on how to avoid major bleeding events while using the blood-thinning drug Pradaxa, which is a major money maker for Boehringer Ingelheim.

The agency says data still shows a positive risk-benefit balance of the drug, even in the face of reports of fatal bleeding cases.

Pradaxa was originally touted as a “miracle drug” of sorts, replacing the longtime standard Coumadin, which is harder to regulate, and has a lengthy laundry list of drug interactions and side effects. It is prescribed to patients with atrial fibrillation after hip and knee surgery to prevent strokes. Atrial fibrillation is a common disorder among the elderly population.

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