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FDA Safety Study and Assessment in NVAF | Pradaxa® (dabigatran etexilate) Skip to main content
  • References:
  • 1. Data on file. Boehringer Ingelheim Pharmaceuticals, Inc.
  • 2. Graham DJ, Reichman ME, Wernecke M, et al. Cardiovascular, bleeding, and mortality risks in elderly Medicare patients treated with dabigatran or warfarin for nonvalvular atrial fibrillation. Circulation. 2015;131(2):157‑164.
  • 3. FDA drug safety communication: FDA study of Medicare patients finds risks lower for stroke and death but higher for gastrointestinal bleeding with Pradaxa (dabigatran) compared to warfarin [press release]. Silver Spring, MD: U.S. Food and Drug Administration; May 13, 2014. http://www.fda.gov/downloads/drugs/drugsafety/ucm397606.pdf. Accessed on June 12, 2015.
  • 4. Southworth MR, Reichman ME, Unger EF. Dabigatran and postmarketing reports of bleeding. N Engl J Med. 2013;368(14):1272‑1274.
  • 5. FDA drug safety communication: update on the risk for serious bleeding events with the anticoagulant Pradaxa [press release]. Silver Spring, MD: U.S. Food and Drug Administration; November 2, 2012. http://www.fda.gov/drugs/drugsafety/ucm326580.htm. Accessed on June 12, 2015.