Evaluation of Dabigatran Bleeding Adverse Reaction Reports in the FDA Adverse Event Reporting System during the First Year of Approval. Issue 6 (19th March 2014)

• Record Type: Journal Article
• Authors: McConeghy, Kevin W.; Bress, Adam; Qato, Dima M.; Wing, Coady; Nutescu, Edith A.
• Is Part Of: Pharmacotherapy. Volume 34:Issue 6(2014)
• Page Start: 561
• Page End: 569
• Publication Date: 2014-03-19
• Subjects: Chemotherapy -- Periodicals; Pharmacology -- Periodicals; Drug Therapy -- Periodicals; Pharmacology -- Periodicals; 615.1
• DOI: 10.1002/phar.1415
• Languages: English
• ISSNs: 0277-0008

Abstract

<abstract abstract-type="main" id="phar1415-abs-0001"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="phar1415-sec-0001" sec-type="section"> <title>Study Objective</title> <p>Evaluate dabigatran adverse event reports with a reported bleeding event and/or reported fatal outcome compared with warfarin.</p> </sec> <sec id="phar1415-sec-0002" sec-type="section"> <title>Design</title> <p>Retrospective analysis of the FDA Adverse Event Reporting System (FAERS) database.</p> </sec> <sec id="phar1415-sec-0003" sec-type="section"> <title>Measurements and Main Results</title> <p>We identified reports from October 1, 2010, through December 31, 2011, in the United States listing dabigatran or warfarin as the primary suspected agent. Bleeding events and related outcomes were determined. A bleeding‐related mortality rate was calculated based on national dabigatran treatment data.</p> </sec> <sec id="phar1415-sec-0004" sec-type="section"> <title>Results</title> <p>Dabigatran was the primary suspected agent in 9029 adverse reports. Of these, 2347 (26%) were bleeding events; a fatal outcome was reported in 348 (15%) of the bleeding events. In comparison, warfarin was the suspected agent in 2038 reports, of which 647 (32%) were reported as bleeding events. Among the warfarin bleeding reports, 46 (7.1%) reported a fatal outcome. Based on national dabigatran use and adverse bleed reports with fatal outcomes, we estimate a lower bound of 150 bleeding‐related fatalities per 100, 000 dabigatran patient‐years. Because of underreporting bias, these estimates represent a lower bound on the population bleeding mortality rates.</p> </sec> <sec id="phar1415-sec-0005" sec-type="section"> <title>Conclusion</title> <p>Reports from FAERS are subject to significant bias but suggest that fatal outcomes among dabigatran reports are higher in clinical practice than they were in controlled clinical trials.</p> </sec> </abstract>