title: Dabigatran and postmarketing reports of bleeding.
authors.affiliation: Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Mary Ross
authors.initials: MR
authors.lastname: Southworth
authors.forename: Marsha E
authors.initials: ME
authors.lastname: Reichman
authors.forename: Ellis F
authors.initials: EF
authors.lastname: Unger
mesh_terms: D000925:Anticoagulants / Q000009:adverse effects; D000991:Antithrombins / Q000009:adverse effects*; D001562:Benzimidazoles / Q000009:adverse effects*; D000069604:Dabigatran; D006471:Gastrointestinal Hemorrhage / Q000139:chemically induced; D006470:Hemorrhage / Q000139:chemically induced*; D006801:Humans; D020300:Intracranial Hemorrhages / Q000139:chemically induced; D011358:Product Surveillance, Postmarketing; D016032:Randomized Controlled Trials as Topic; D014481:United States; D014486:United States Food and Drug Administration; D014859:Warfarin / Q000009:adverse effects; D015091:beta-Alanine / Q000009:adverse effects / Q000031:analogs & derivatives*
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D001562:Benzimidazoles; D015091:beta-Alanine; D014859:Warfarin; D000069604:Dabigatran