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Pradaxa News
Bleeding Higher With Standard-Dose DOACs in Nonvalvular A-Fib
THURSDAY, Nov. 16, 2023 – For nursing home residents with nonvalvular atrial fibrillation, the rate of bleeding is higher with standard- versus reduced-dose direct acting oral anticoagulants...
DOACs Reduce Dementia Risk Versus Warfarin in A-Fib
THURSDAY, Sept. 7, 2023 – For patients with atrial fibrillation (AF), the use of direct-acting oral anticoagulants (DOACs) significantly reduces dementia risk compared with warfarin, according to a...
FDA Approves Pradaxa (dabigatran) as First Oral Blood Thinning Medication for Children
June 21, 2021 – Today, the U.S. Food and Drug Administration approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism (a...
FDA Provides Full Approval to Praxbind (idarucizumab), Specific Reversal Agent for Pradaxa
Ridgefield, Conn., April 17, 2018 – Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has provided full approval for Praxbind (idarucizumab), the specific reversal ...
FDA Approves Praxbind (idarucizumab) as a Reversal Agent for the Anticoagulant Pradaxa
October 16, 2015 – The U.S. Food and Drug Administration today granted accelerated approval to Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran)...
FDA Medwatch Alert: Pradaxa (dabigatran): Drug Safety Communication - Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin
ISSUE: The FDA recently completed a new study in Medicare patients comparing Pradaxa to warfarin, for risk of ischemic or clot-related stroke, bleeding in the brain, major gastrointestinal (GI) ...
FDA Approves Pradaxa for Deep Venous Thrombosis and Pulmonary Embolism
Ridgefield, CT, April 7, 2014 – Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Pradaxa® (dabigatran etexilate mesylate) for th...
FDA Medwatch Alert: Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Should Not Be Used in Patients with Mechanical Prosthetic Heart Valves
ISSUE: The U.S. Food and Drug Administration (FDA) is informing health care professionals and the public that the blood thinner (anticoagulant) Pradaxa (dabigatran etexilate mesylate) should not be...
FDA Medwatch Alert: Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events
UPDATED 11/02/2012. The FDA evaluated new information about the risk of serious bleeding associated with use of the anticoagulants (blood thinners) dabigatran (Pradaxa) and warfarin (Coumadin,...
FDA Medwatch Alert: Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events
ISSUE: (FDA) is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Bleeding that may lead to serious or even fatal outcomes is a...
FDA Medwatch Alert: Pradaxa (dabigatran etexilate mesylate) Capsules: Special Storage and Handling Requirements
ISSUE: FDA is alerting the public to important storage and handling requirements for Pradaxa (dabigatran etexilate mesylate) capsules. Due to the potential for product breakdown from moisture and...
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Prevention of Thromboembolism in Atrial Fibrillation, Pulmonary Embolism, Deep Vein Thrombosis (DVT), Deep Vein Thrombosis, Deep Vein Thrombosis - Prophylaxis