FDA will evaluate the safety of new anticoagulant dabigatran

Source: dxy-2014-1-8 FDA will start a large-scale study to evaluate the safety of pradaxa, a new anticoagulant of Boehringer Ingelheim, based on warfarin, such as bleeding, thrombus, etc In this study, FDA launched the "mini sentinel program" in 2008 to collect daily electronic medical data and actively monitor the safety of pradaxa products in the market At present, dabigatran has been approved by FDA to reduce the risk of stroke and systemic embolism in patients with non valvular atrial fibrillation (NVAF) The drug is the first oral anticoagulant approved by FDA for this indication in the past 50 years Dabigatran ester has the characteristics of oral administration, strong effect, no need for special drug monitoring and less drug interaction Previous evaluation showed that the bleeding rate associated with the new use of dabigatran was not higher than that associated with warfarin According to the guidance, the benefit of the drug is still greater than the risk The medical staff who prescribe dabigatran should follow the recommended dose specified in the product manual (especially for patients with renal function damage) to reduce the risk of bleeding Patients with AF should not stop using dabigatran Discontinuation of anticoagulants such as dabigatran may increase the risk of stroke, which may lead to permanent disability or death Pradaxa's global sales reached 1.1 billion euros in 2012, according to Boehringer Ingelheim Pradaxa's competitors include Bayer and Johnson's xarelto, and Squibb and Pfizer's eliquis But so far, FDA has not planned to evaluate the safety of the latter two.