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Dabigatran News
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...
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