Since the approval of dabigatran (Pradaxa, Boehringer Ingelheim) in Europe in 2008 and in the US in 2010 there have been persistent and lingering considerations about the drug’s security. Now the FDA strategies to complete a huge new evaluation of the drug compared to warfarin.
On December thirty the FDA posted a request for public comment on a proposed protocol of the study, which it describes as “a one-time assessment of chosen security outcomes in grownups with atrial fibrillation who are new customers of dabigatran or warfarin.” The research will “assess systematically the costs of bleeding and thromboembolic outcomes connected with the use of dabigatran and warfarin for individuals with atrial fibrillation using data from the FDA Mini-Sentinel Distributed Database (MSDD).”
The Mini-Sentinel undertaking is a component of the FDA’s Sentinel energetic surveillance technique. Mini-Sentinel, according to the FDA, employs pre-current electronic healthcare data from several sources. The Mini-Sentinel database, the FDA notes, “is not so ‘mini’,” as it consists of 17 data partners and makes use of data from virtually one hundred million individuals.
At this stage there is no plan to assess the safety of the new oral anticoagulants that received approval after dabigatran, rivaroxaban (Xarelto, Johnson & Johnson) and Eliquis (Pfizer and BristolMysers Squibb).
A experienced source mentioned that the major goal of the examine will be to recognize groups of sufferers who are at higher chance for significant bleeding events with dabigatran. Relatively paradoxically, this may well help bolster the drug, as it will then also identify groups more likely to advantage from therapy. On the other hand, the truth that equivalent scientific studies are not getting undertaken with the other new oral anticoagulants may possibly nicely reinforce issues about dabigatran.
FDA Plans New Safety Evaluation Of Dabigatran (Pradaxa)
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