Pradaxa Bleeding Deaths Spur FDA Concerns, European Label Changes
This article was originally published in The Pink Sheet Daily
FDA is investigating reports that more patients are experiencing serious bleeding events after taking Boehringer Ingelheim GmbH’s Pradaxa (dabigatran) than anticipated based on clinical trial results.
You may also be interested in...
Revamped ANDA instructions – among new and revised draft guidance for 58 products announced by FDA – 'account for the fact that dabigatran exhibits large within-subject variability with respect to blood levels.'
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.