FDA's Pradaxa Quandary: Clearing Both Doses Could Mask Dabigatran's Superiority
The pivotal issue remaining for FDA's review of Boehringer Ingelheim's Pradaxa (dabigatran) is whether it will clear both the 110 mg and 150 mg doses and how it can craft labeling to guide appropriate use toward the higher dose, which seems likely to gain a superiority claim over warfarin.
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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.
British Medical Journal investigation focuses mainly on Boehringer’s direct thrombin inhibitor Pradaxa, but also suggests that all novel anticoagulants could benefit from testing to ensure the right anticoagulant dose is being given, for safety’s sake.
FDA’s decision to approve the 150 mg strength of Boehringer Ingelheim GmbH’s antithrombotic Pradaxa (dabigatran), but not the 110 mg dose, reflects agency doubts about the ability of risk management tools to change prescriber behavior that is likely to result in inappropriate use of a less effective dose.