Dabigatran Bleeding Complications Are Not More Common than Expected

Dabigatran is safer than warfarin, and reporting bias explains high numbers of reported complications.

Dabigatran was approved in October 2010 for stroke prevention in patients with atrial fibrillation. Following its approval, the U.S. Food and Drug Administration (FDA) received an unexpected number of reports of bleeding complications, and news media raised the possibility that this agent was not as safe in general use as it had been in controlled clinical trials. In December 2011, the FDA issued a drug safety communication warning of bleeding risks (http://www.fda.gov/drugs/drugsafety/ucm282724.htm).

Using an insurance claims database, FDA investigators quantified bleeding events in dabigatran and warfarin recipients from the date of approval through December 2011. The rate of gastrointestinal hemorrhage was 1.6 per 100,000 days of treatmen…

Reviewing Author

Daniel J. Pallin, MD, MPH

Disclosures

Consultant/Advisory BoardPortola Pharmaceuticals, Inc.

Speaker’s BureauPeerView Institute for Medical Education

Grant/Research SupportAgency for Healthcare Research and Quality; CDC; NIH–National Center for Advancing Translational Sciences; NIH–National Institute of Allergy and Infectious Diseases (NIAID); NIH–NIAID–Antibacterial Resistance Leadership Group; Merck; Pfizer; Boehringer-Ingelheim; Shire; Portola Pharmaceuticals, Inc.; Novartis; bioMérieux; Siemens; Rapid Pathogen Screening; Magnolia; Stago; Innovative Biosensors; Molecular Detection, Inc.; Dyax Corp.; Trius Pharmaceuticals

Daniel J. Pallin, MD, MPH

Disclosures

Consultant/Advisory BoardPortola Pharmaceuticals, Inc.

Speaker’s BureauPeerView Institute for Medical Education

Dabigatran Bleeding Complications Are Not More Common than Expected

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Reviewing Author