Alembic Pharma gets tentative USFDA nod for generic version of Dabigatran Etexilate capsules
The tentatively approved ANDA is therapeutically equivalent to the reference listed drug (RLD) product Pradaxa Capsules, 75 mg, 110 mg, and 150 mg of Boehringer Ingelheim Pharmaceuticals, Inc (Boehringer) (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - April 7, 2022 Category: Pharmaceuticals Source Type: news

Rivaroxaban May Lead to Higher GI Bleeding Risk Than Other DOACs Rivaroxaban May Lead to Higher GI Bleeding Risk Than Other DOACs
Rivaroxaban was associated with an increased risk of overall and major gastrointestinal bleeding, compared with apixaban or dabigatran, a study shows.Medscape Medical News (Source: Medscape Internal Medicine Headlines)
Source: Medscape Internal Medicine Headlines - October 12, 2021 Category: Internal Medicine Tags: Internal Medicine News Source Type: news

Dabigatran Reversal With Idarucizumab in Urgent Surgery Dabigatran Reversal With Idarucizumab in Urgent Surgery
Is this strategy a safe and effective means of anticoagulation reversal in patients requiring urgent surgery?Annals of Surgery (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - September 13, 2021 Category: Consumer Health News Tags: General Surgery Journal Article Source Type: news

FDA OKs First Oral Blood Thinning Medication for Children
TUESDAY, June 22, 2021 -- The first oral blood thinning medication for children was approved by the U.S. Food and Drug Administration, the agency announced Monday. Pradaxa (dabigatran etexilate) oral pellets were approved to treat children ages 3... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - June 22, 2021 Category: Pharmaceuticals Source Type: news

FDA Approves First Oral Anticoagulant for Children FDA Approves First Oral Anticoagulant for Children
Dabigatran etexilate oral pellets become the only anticoagulant for children that does not require injection.FDA Approvals (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - June 22, 2021 Category: Cardiology Tags: Pediatrics News Alert Source Type: news

FDA approves first oral blood thinning medication for children
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 condition where blood clots form in the veins) directly after they have been treated with a blood thinner given by injection for at least five days. (Source: World Pharma News)
Source: World Pharma News - June 22, 2021 Category: Pharmaceuticals Tags: Featured FDA Regulatory Affairs Source Type: news

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 condition where blood clots form in the veins)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 21, 2021 Category: Drugs & Pharmacology Source Type: news

Comunicado de la FDA sobre la seguridad de los medicamentos: Pradaxa (dabigatr án etexilato mesilato) no se debe usar en pacientes con válvulas protésicas del corazón
El 19 de diciembre del 2012, La Administraci ón de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) informó al público y profesionales de la salud que el anticoagulante Pradaxa (dabigatrán etexilato mesilato) no se debe utilizar para evitar derrames cerebrales o coágulos de sangre (sucesos tromboembólicos severo s) en pacientes con válvulas mecánicas del corazón, también conocidas como válvulas mecánicas protésicas del corazón. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 11, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Comunicado de la FDA sobre la seguridad de los medicamentos: Actualizaci ón sobre el riesgo de eventos severos de hemorragia con el anticoagulante Pradaxa (dabigatrán etexilato mesilato)
[5 de noviembre del 2012. La Administraci ón de Alimentos y Medicamentos de Estados Unidos (FDA pos sus siglas en inglés) ha evaluado nueva información sobre hemorragias severas con el uso de los anticoagulantes dabigatrán (Pradaxa) y warfarina (Coumadin, Jantoven y medicamentos genéricos). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 4, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Positive-CHMP-opinion-for-dabigatran-in-children
Boehringer Ingelheim receives positive CHMP opinion for use of Pradaxa ® (dabigatran etexilate) for the treatment and prevention of venous thromboembolic events in children from birth to less than 18 years of ageNo approved therapy for the treatment and prevention of venous thromboembolic events in children until nowCurrent standard of care often associated with frequent monitoring of anticoagulation or daily injections1Positive opinion is based on a dedicated clinical pediatric program for dabigatran, including the DIVERSITY study,2 which supplements dabigatran ´s established and well-documented safety and efficacy prof...
Source: Boehringer Ingelheim Corporate News - November 13, 2020 Category: Research Source Type: news

Direct-acting oral anticoagulants (DOACs): reminder of bleeding risk, including availability of reversal agents, MHRA (drug safety update 29th June 2020)
Remain vigilant for signs and symptoms of bleeding complications during treatment with DOACs (apixaban, dabigatran, edoxaban, rivaroxaban), especially in patients with increased bleeding risks. Specific reversal agents are available for dabigatran (Praxbind ▼, idarucizumab), and apixaban and rivaroxaban (Ondexxya▼, andexanet alfa). (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - June 29, 2020 Category: Consumer Health News Source Type: news

rt-PA in Ischemic Stroke After Idarucizumab Administration rt-PA in Ischemic Stroke After Idarucizumab Administration
This case demonstrates that thrombolytic therapy with rt-PA after reversal of dabigatran with idarucizumab may be safe and feasible in patients with acute ischemic stroke with lacunar infarct.Journal of Medical Case Reports (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - February 4, 2020 Category: Consumer Health News Tags: Family Medicine/Primary Care Journal Article Source Type: news

Cost effectiveness of dabigatran: value of real-world data
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - October 31, 2019 Category: Drugs & Pharmacology Source Type: news

Medical News Today: Existing blood thinner delays Alzheimer's disease in mice
New research in mice suggests that dabigatran, a blood thinning drug, may help delay the development of Alzheimer's by maintaining normal brain blood flow. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - October 8, 2019 Category: Consumer Health News Tags: Alzheimer's / Dementia Source Type: news

Idarucizumab Reverses Dabigatran Regardless of Renal Function Idarucizumab Reverses Dabigatran Regardless of Renal Function
In a RE-VERSE AD subgroup analysis, idarucizumab reversed the effects of dabigatran in more than 98% of patients, regardless of renal function.Medscape Medical News (Source: Medscape Neurology and Neurosurgery Headlines)
Source: Medscape Neurology and Neurosurgery Headlines - October 1, 2019 Category: Neurology Tags: Cardiology News Source Type: news