descriptionPublicationkeyboard_double_arrow_right Article 23 Jul 2014 English Publisher:BMJJournal:BMJ, volume 349, pages g4517-g4517 (eissn: 1756-1833,

Authors: Donald R. Mattison; Thomas J. Moore; Michael R. Cohen;

doi: 10.1136/bmj.g4517

pmid: 25056265

Dabigatran, bleeding, and the regulators

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Abstract

Thomas J Moore and colleagues highlight the differences in how US and European regulators managed the safety problems of the new anticoagulant dabigatran and ask both to think again and mandate plasma monitoring of dabigatran

Related Organizations

Institute for Safe Medication Practices
United States
University of Ottawa
Canada

Keywords

Clinical Trials as Topic, Dose-Response Relationship, Drug, United States Food and Drug Administration, Hemorrhage, Antithrombins, United States, Dabigatran, Europe, Product Surveillance, Postmarketing, beta-Alanine, Humans, Benzimidazoles, Warfarin, Drug Monitoring, Drug Approval

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