Dabigatran, bleeding, and the regulators.

The article discusses the measures taken by the U.S. and European regulators in managing the safety problems associated with anticoagulant dabigatran. Topics discussed include the U.S. Food and Drug Administration's marketing approval to dabigatran in 2010 after completing its own pharmacokinetic and pharmacodynamic modelling, the European Medicines Agency's emphasis on measures to minimize bleeding risks of dabigatran, and risks and benefits of 110 milligram dabigatran dose.