• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Scientific Publications by FDA Staff

  • Print
  • Share
  • E-mail

Search Publications



Starting Date

Ending Date

Order by

Entry Details

N Engl J Med 2013 Apr 4;368(14):1272-4

Dabigatran and Postmarketing Reports of Bleeding.

Southworth MR, Reichman ME, Unger EF


In the months following the approval of the oral anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim) in October 2010, the Food and Drug Administration (FDA) received through the FDA Adverse Event Reporting System (FAERS) many reports of serious and fatal bleeding events associated with use of the drug. Because dabigatran is an anticoagulant, reports of bleeding were anticipated, but the rate of reported incidents was unusually high and was greater than the concurrent rate of reported bleeding incidents with warfarin, which had been the anticoagulant of choice for nearly 60 years before dabigatran was approved. In contrast, the controlled trial that supported . . .

Category: Journal Article, Editorial
PubMed ID: #23484796 DOI: 10.1056/NEJMp1302834
Includes FDA Authors from Scientific Area(s): Drugs
Entry Created: 2013-03-15 Entry Last Modified: 2013-05-12