How Safe is Dabigatran in Elderly?

  • Kamile Silay Yildirim Beyazit university, Faculty of Medicine, Department of Geriatrics
  • Sema Akinci
  • Arife Ulas
  • Ahmet Yalcin
Keywords: Dabigatran, elderly, bleeding, drug interaction


The aim is to report a case of dabigatran induced gastrointestinal bleeding without any obvious source and emphasize the risk of drug interaction in an elderly patient. An 87 year-old female who was treated with dabigatran and nifedipine for nonvalvular atrial fibrillation developed gastrointestinal bleeding. Endoscopy and colonoscopy was performed and no pathology was identified. Bleeding stopped spontaneously. Our case suggests that drug interactions may increase the risk of bleeding additional to old age in patients who are treated with dabigatran.  Clinicians should use these medications with caution in geriatric population particularly over 85 years old.


-Pradaxa (dabigatran etexilate mesylate) capsules [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; September 2014.

-Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet. 2008; 47: 285-95.

-Connolly SJ, Ezekowitz MD, Yusuf S, et al; RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation [published correction appears in N Engl J Med. 2010;363:1877]. N Engl J Med. 2009; 361: 1139-51.

-Stangier J, Rathgen K, Stähle H, Mazur D. Influence of renal impairment on the pharmacokinetics and pharmacodynamics of oral dabigatran etixilate: an open-label, parallel-group, single centre study. Clin Pharmacokinet. 2010; 49: 259-68.

-Institute for Safe Medication Practices. Monitoring FDA MedWatch Reports: Anticoagulants the leading reported drug risk in 2011. Published May 31, 2012.

-Gosselin RC, Dwyre DM, Dager WE. Measuring dabigatran concentrations using a chromogenic ecarin clotting time assay. Ann Pharmacother. 2013;47: 1635-40.

-Anastasia L. A., Katie S. Buehler, Sun H. Min, Margaret Riley, Michael W. Daly. Evaluation of Dabigatran for Appropriateness of Use and Bleeding Events in a Community Hospital Setting. Am Health Drug Benefits. 2014; 7: 376-84

-Wittkowsky AK. Novel oral anticoagulants and their role in clinical practice. Pharmacotherapy. 2011; 31: 1175-1191.

-Béné J1, Saïd W, Rannou M, Deheul S, Coupe P, Gautier S. Rectal bleeding and hemostatic disorders induced by dabigatran etexilate in 2 elderly patients. Ann Pharmacother. 2012;46: e14.