Regulators were kept in the dark about important data Boehringer Ingelheim had about the safety of its oral direct thrombin inhibitor dabigatran (Pradaxa) while the drug was under review for approval in nonvalvular atrial fibrillation (AF), according to several documents published Wednesday in the British Medical Journal (BMJ).
The four documents indicate that Boehringer Ingelheim didn’t share its own analysis with U.S. or European regulators suggesting a severe reduction in bleeding risk when Pradaxa was dosed with guidance from anticoagulation monitoring. It is likely this information was withheld because if it made its way to the regulators, it would have undermined the key Pradaxa marketing message that no such monitoring would be required, MedScape.com reported. One of alleged benefits of Pradaxa was that unlike warfarin, routine monitoring was not required. More Pradaxa-maker Kept FDA in Dark about Bleeding Risks