Treatment visits for use of anticoagulants are on an upward trend and driven largely by the popularity of new direct oral anticoagulants, which tripled in use from 2013-2014.
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Three major updates were added to the prescribing information for Pradaxa capsules, an oral anticoagulant. One included a warning that discontinuing treatment puts patients at increased risk of stroke.
Boehringer Ingelheim announced that it is conducting a nationwide recall of a single manufacturing lot of Pradaxa (dabigatran etexilate mesylate) capsules 75mg.
Complete reversal was seen within 4 hours in the majority of patients, as measured by ecarin clotting time (ECT 82%) or diluted thrombin time (dTT 99%). In addition, there was a low late of thrombotic events and no new safety events were reported.
Boehringer Ingelheim has issued a statement regarding a recent article published in BMJ on the use of Pradaxa (dabigatran etexilate mesylate) and monitoring of anticoagulant activity and plasma levels.
As many as 25 percent of patients with atrial fibrillation (AF) at the lowest risk for stroke may be taking oral anticoagulants despite current guidelines, according to a research letter published online in JAMA Internal Medicine.
Boehringer Ingelheim announced that the FDA has accepted for filing the supplemental New Drug Application (sNDA) for Pradaxa (dabigatran etexilate mesylate) for the prophylaxis of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have had primary elective total hip replacement surgery.
The primary safety endpoint was defined as time to major bleeding events and clinically relevant non-major bleeding events when compared to triple therapy with warfarin.
The Food and Drug Administration (FDA) has grated accelerated approval to Praxbind (idarucizumab; Boehringer Ingelheim) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects.
The World Health Organization (WHO) has updated the WHO Model List of Essential Medicines for 2019.