Epistaxis associated with dabigatran in an elderly patient with reduced creatinine clearance

American Journal of Health-System Pharmacy

Volumn 69, Issue 14, 2012, Pages

  Freshour, Jessica E ^a   Hudson, Joanna Q ^b   Stevens, Amy B ^c   Franks, Andrea S ^b  

^a EAST TENNESSEE STATE UNIVERSITY   (United States)

^b UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER   (United States)

^c UNIVERSITY OF TENNESSEE GRADUATE SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DABIGATRAN ETEXILATE; WARFARIN;

AGED; BLEEDING; CASE REPORT; CREATININE CLEARANCE; DEEP VEIN THROMBOSIS; DRUG ELIMINATION; DRUG INDICATION; DRUG LABELING; ELDERLY CARE; EMBOLISM; EMERGENCY WARD; EPISTAXIS; FEMALE; FOOD AND DRUG ADMINISTRATION; HEART ATRIUM FIBRILLATION; HUMAN; KIDNEY FUNCTION; LETTER; NOSE SEPTUM RECONSTRUCTION; PATIENT SAFETY; PRIORITY JOURNAL; STROKE; SURGICAL APPROACH; SURGICAL TECHNIQUE;

EID: 84863919737     PISSN: 10792082     EISSN: 15352900     Source Type: Journal    
DOI: 10.2146/ajhp110644     Document Type: Letter

References (9)

1. Beasley BN, Unger EF, Temple R. Anticoagulant options: why the FDA approved a higher but not lower dose of dabigatran. N Engl J Med. 2011; 364:1788-90.
2. Connolly SJ, Ezekowitz MD, Eikelboom YS et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009; 361:1139-51.
3. Ezekowitz MD, Connolly S, Parekh A et al. Rationale and design of RE-LY: randomized evaluation of long-term anticoagulant therapy, warfarin compared with dabigatran. Am Heart J. 2009; 157:805-10.
4. Pradaxa (dabigatran etexilate) package insert. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; 2011 Mar.
5. Ezekowitz MD, Wallentin L, Connolly SJ et al. Dabigatran and warfarin in vitamin K antagonist-naïve and -experienced cohorts with atrial fibrillation. Circulation. 2010; 122:2246-53.
6. European Medicines Agency. Pradaxa EPAR. www.ema.europa.eu/docs/en-GB/ document-library/EPAR---Summary-for-the-publ i c / human/000829/WC500041060.pdf (accessed 2011 Jul 22).
7. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976; 16:31-41.
8. Drusano GL, Munice HL, Hoopes JM et al. Commonly used methods of estimating creatinine clearance are inadequate for elderly debilitated nursing home patients. J Am Geriatr Soc. 1988; 36:437-41.
9. Food and Drug Administration. Guidance for industry: pharmacokinetics in patients with impaired renal function - study design, data analysis, and impact on dosing and labeling, 1998. www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatory Information/Guidances/ucm072127.pdf (accessed 2011 Jul 21).