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Dabigatran News
Improved Calculator Predicts Stroke Risk For A-Fib Patients
MONDAY, Aug. 11, 2025 — A newly refined test can help detect which people with abnormal heart rhythms need treatment for an increased risk of stroke, researchers report. Adding blood tests to an e...
Bleeding Risks for Oral Anticoagulants and Aspirin Mostly Similar
TUESDAY, Feb. 11, 2025 – Rates of major bleeding and intracranial hemorrhage are similar for apixaban and dabigatran versus aspirin, while rates are higher for rivaroxaban, according to a review...
FDA Medwatch Alert: Ascend Laboratories LLC. Issues Voluntary Nationwide Recall of Dabigatran Etexilate Capsules, USP 75 mg and 150 mg, Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
March 22, 2023 - Parsippany. New Jersey. Ascend Laboratories LLC. is voluntarily recalling Dabigatran Etcxilate Capsules. USP 75 mg and 150 mg to the consumer/user level due to the presence of 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...
Further information
Related condition support groups
Prevention of Thromboembolism in Atrial Fibrillation, Deep Vein Thrombosis - Prophylaxis, Pulmonary Embolism, Deep Vein Thrombosis (DVT), Deep Vein Thrombosis