FDA’s Pradaxa Review Overemphasized Efficacy, Safety Experts Argue

Critique in the British Medical Journal of FDA’s review of Boehringer Ingelheim’s anticoagulant concludes agency should have approved a low-dose version, touching off a classic drug safety debate about the value of encouraging use of a potentially risky product.

FDA should have approved a lower dose of Boehringer Ingelheim GMBH’s Pradaxa, safety experts charge in an article published in the British Medical Journal on July 23.

Pradaxa (dabigatran) was approved in October 2010 at a 150 mg twice-daily dose for reducing risk of stroke in atrial...

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