Dabigatran and Post Marketing reports of bleeding

After dabigatran (PRADAXA) was approved in October 2010, the FDA received reports of serious and fatal bleeding that appeared unusually high. Because of this, the FDA began reviewing reports received by the FDA Adverse Event Reporting System (FAERS). Because the report generated by FAERS did not include information on patient’s risk factors, age, renal function or cause of death, consideration then turned to the possibility of a greater likelihood of reporting a bleeding event because dabigatran was new to the market. A second study was conducted using insurance claims and administrative data from the FDA Mini-Sentinel database, covering a period from October 19, 2010 to December 31, 2011. The finding was that bleeding rates of dabigatran were not higher than the bleeding rates associated with warfarin. Because this analysis in itself had limitations, further ongoing studies are now being conducted. The conclusion made was that “dabigatran provides an important health benefit when used as directed.”


  1. Dabigatran and Postmarketing Reports of Bleeding, Mary Ross Southworth, Pharm.D., Marsha E. Reichman, Ph.D., and Ellis F. Unger, M.D., N Engl J Med 2013; 368:1272-1274April 4, 2013DOI: 10.1056/NEJMp1302834