Dabigatran and postmarketing reports of bleeding

New England Journal of Medicine

Volumn 368, Issue 14, 2013, Pages 1272-1274

  Southworth, Mary Ross ^a   Reichman, Marsha E ^a   Unger, Ellis F ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DABIGATRAN ETEXILATE; WARFARIN;

BLEEDING; BRAIN HEMORRHAGE; CEREBROVASCULAR ACCIDENT; DISEASE ASSOCIATION; DRUG MONITORING; DRUG SAFETY; EMBOLISM; GASTROINTESTINAL HEMORRHAGE; HUMAN; OUTCOME ASSESSMENT; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; RISK FACTOR; SHORT SURVEY;

EID: 84875780959     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp1302834     Document Type: Article

References (4)

1. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361:1139-51. [Erratum, N Engl J Med 2010;363:1877.]
2. Weber JCP. Epidemiology of adverse reactions to nonsteroidal anti-inflammatory drugs. Adv Inflamm Res 1984;6:1-7.
3. FDA drug safety communication: safety review of post-market reports of serious bleeding events with the anticoagulant Pradaxa (dabigatran etexilate mesylate) (http://www.fda.gov/drugs/drugsafety/ucm282724.htm).
4. FDA Sentinel Initiative. Mini-Sentinel home page (http://mini-sentinel. org).