FDA Looking At Pradaxa (Dabigatran) With A Closer Eye
Since the approval of dabigatran (Pradaxa, Boehringer Ingelheim) in Europe in 2008 and in the US in 2010 there have been serious concerns about the drug’s safety. The FDA has just announced that it plans to perform a new large assessment of Pradaxa compared to warfarin.
On December 30 the FDA posted a request for public comment on a proposed protocol of the study, which it describes as “a one-time assessment of selected safety outcomes in adults with atrial fibrillation who are new users of dabigatran or warfarin.” The study will “assess systematically the rates of bleeding and thromboembolic outcomes associated with the use of dabigatran and warfarin for patients with atrial fibrillation using data from the FDA Mini-Sentinel Distributed Database (MSDD).”
At this point there is no plan to assess the safety of the new oral anticoagulants that received approval after Pradaxa, which include rivaroxaban (Xarelto, Johnson & Johnson) and Eliquis (Pfizer and BristolMysers Squibb).
There have been serious reports of people having major bleeding events with dabigatran (Pradaxa). Some of these events have been deadly.