The trouble with dabigatran

BMJ (Online)

Volumn 349, Issue , 2014, Pages

  Charlton, Blake ^a   Redberg, Rita ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DABIGATRAN; WARFARIN;

CEREBROVASCULAR ACCIDENT; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG INDICATION; DRUG INDUSTRY; DRUG MONITORING; DRUG SAFETY; DRUG TOLERANCE; DRUG USE; EDITORIAL; EMBOLISM; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL HEMORRHAGE; HUMAN; MEDICAL DECISION MAKING; MEDICAL DOCUMENTATION; PATIENT CARE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK ASSESSMENT;

ANTITHROMBINS; BENZIMIDAZOLES; BETA-ALANINE; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG APPROVAL; DRUG MONITORING; HEMORRHAGE; HUMANS; PRODUCT SURVEILLANCE, POSTMARKETING; RANDOMIZED CONTROLLED TRIALS AS TOPIC; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84904866522     PISSN: None     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.g4681     Document Type: Editorial

References (10)

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3. Moore TJ, Cohen MR, Mattison DR. Dabigatran, bleeding, and the regulators. BMJ 2014;349:g4517.
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6. US Food and Drug Administration. Pradaxa (dabigatran etexilate mesylate): drug safety communication - safety review of post-market reports of serious bleeding events. 2011.www.fda.gov/safety/medwatch/safetyinformation/ safetyalertsforhumanmedicalproducts/ucm282820.htm.
7. Sipahi I, Celik S, Tozun N. A comparison of results of the US Food and Drug Administration's Mini-Sentinel program with randomized clinical trials: the case of gastrointestinal tract bleeding with dabigatran. JAMA Intern Med 2014;174:150-1.
8. Reilly PA, Lehr T, Heartter S, Connolly SJ, Yusuf S, Eikelbloom JW, et al. The effects of dabigatran plasma concentrations and patient characteristics on the frequency of ischemic stroke and major bleeding in atrial fibrillation patients. J Am Coll Cardiol 2014;63:321-8.
9. Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the euro heart survey on atrial fibrillation. Chest 2010;137:263-72.
10. Lip GY, Frison L, Halperin JL, Lane DA. Comparative validation of a novel risk score for predicting bleeding risk in anticoagulated patients with atrial fibrillation: the HAS-BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly) score. J Am Coll Cardiol 2011;57:173.