Dabigatran and Postmarketing Reports of Bleeding

Southworth, Mary Ross; Reichman, Marsha E.; Unger, Ellis F.

doi:10.1056/nejmp1302834

Cited by 317 publications

(238 citation statements)

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“…Since dabigatran's approval for clinical use by the Food and Drug Administration (FDA) and European Medicines Agency (EMEA), numerous reports have appeared of bleeding complications [7][8][9][10][11][12][13][14][15][16][17]. In the Randomized Evaluation of Long-term anticoagulation therapY (RE-LY) study, the rate of overall major bleeding was similar between dabigatran and warfarin.…”

Section: Introductionmentioning

confidence: 99%

“…Further, while intracranial bleeding was reduced (0.3 versus 0.8 %), gastrointestinal bleeding was greater (1.6 versus 1.1 %) in dabigatran-treated patients [18]. The majority of data suggest that the risk of major hemorrhage with dabigatran is at least similar to warfarin [7,10,[19][20][21]. Although voluntary reporting of dabigatran-related adverse events is almost certainly prone to bias, these cases provide clinicians with valuable information [10,21,22].…”

Section: Introductionmentioning

confidence: 99%

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Enhanced Elimination of Dabigatran Through Extracorporeal Methods

2014

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Several pharmacokinetic studies have suggested that dabigatran possesses a number of ideal properties for expedited removal via extracorporeal methods. However, this practice has not been prospectively evaluated in patients with life-threatening bleeding or requiring emergency surgery secondary to dabigatran-associated coagulopathy. The purpose of this literature review is to evaluate the published evidence surrounding extracorporeal removal of dabigatran in the setting of emergency surgery or life-threatening bleeding. A query of MEDLINE, Web of Science, International Pharmaceutical Abstracts, and Google Scholar using the terms dabigatran, dabigatran etexilate, hemodialysis, renal replacement therapy, hemorrhage, and atrial fibrillation was used to retrieve relevant literature. Furthermore, a manual search of the references of the identified literature was performed to capture additional data. Current evidence suggests that extracorporeal removal of dabigatran may play a role in the setting of life-threatening bleeding and emergent surgery. Conflicting evidence exists with regard to the potential for redistribution based on serum dabigatran concentrations. In addition, a number of practicalities must be considered before incorporating this technique in the clinical setting. Extracorporeal removal of dabigatran may be a treatment modality in selected patients who require emergency reversal.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Enhanced Elimination of Dabigatran Through Extracorporeal Methods

2014

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“…• Avoid dabigatran in patients with elevated risk for gastrointestinal bleeding. 33 • In elderly patients (Ͼ75 years old) or in patients with renal impairment, an adjusted dose of 75 mg bid is preferred.…”

Section: Direct Thrombin Inhibitorsmentioning

confidence: 99%

“…There was no increased risk of major bleeding with apixaban over aspirin. 33 The Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) study compared apixaban with warfarin in Ͼ18,000 patients with AF. This trial was conducted for 1.8 years in over 1000 centers in 39 countries.…”

Section: Apixaban (Eliquis)mentioning

confidence: 99%

Novel Anticoagulants in Atrial Fibrillation: A Primer for the Primary Physician

Mookadam

Shamoun

Mookadam

2015

The Journal of the American Board of Family Medicine

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Atrial fibrillation is a common arrhythmia encountered in clinical practice. The prevalence increases with age. A devastating complication of atrial fibrillation is cardioembolic stroke with central nervous system sequelae. Based on stroke risk scores (CHADS and CHA 2 DS 2 VASc) and bleeding risk (HAS-BLED), the optimal use of anticoagulation in atrial fibrillation is feasible. Warfarin is a proven medication for this specific indication but requires frequent monitoring and dose adjustments, and it has multiple food, drug, and disease-state interactions. In addition, management of anticoagulation during the perioperative period may be challenging. In this regard, novel oral anticoagulants (NOACs) have shown promise in the shift toward the "ideal" anticoagulant therapy, in that fixed dosing is the norm, drug interactions are few, food interactions are absent, onset is fairly immediate and offset predictable, and, in the majority of patients, therapeutic monitoring is not required. This article provides a review of recent published trials of the use of NOACs in atrial fibrillation. Practical points on indications, contraindications, mechanism of action, interactions, and perioperative management tips are discussed with a view toward the safe and effective use of these new medications. When patients are transitioned between different anticoagulant medications, the risks of thrombosis and bleeding need to be considered. When switching from warfarin to a NOAC, the NOAC can be started once the international normalized ratio is

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“…Patients at high risk of bleeding are little represented in studies with DOACs [2,3]. However, from October 2010 to December 2011, vis-à-vis 3.5 gastrointestinal bleedings and 2.4 intracranial hemorrhages/100,000 days at risk in new users of warfarin, 1.6 gastrointestinal bleedings and 0.8 intracranial hemorrhages/100,000 days at risk occurred among new users of Dabigatran in the every day practice in the USA [4].…”

mentioning

confidence: 99%