For the second time in less than a year European regulators have asked Pradaxa manufacturer Boehringer Inglheim (“BI”) to update the drug’s label to include specific information pertaining to bleeding risks.
Pradaxa—a fairly recent direct thrombin inhibitor blood thinner thought to be safer than Coumadin— was approved in Europe in March, 2008 for the prevention of venous thromboembolic events following hip or knee replacement surgery. Recently, European regulators have extended Pradaxa’s approved uses to include the prevention of specific disorders that may cause stroke and systemic embolism.
However, since the drug’s expansion there has been a marked increase in fatal bleeding events, which were initially noted in November, 2011 following the death of 250 patients. At that time the European Medicines Agency ‘s (“EMA”) Committee for Medicinal Products for Human Use asked that BI strengthen the label’s bleeding risk information. Now, the EMA is requiring more of BI: the Pradaxa labels must include more specific information on when the drug must not be used, as well as advice on managing patients and reversing the anticoagulant effect if a bleeding episode does occur.
Perhaps most frightening, while Coumadin also presents a risk of serious internal bleeding, Coumadin bleeding can be readily stopped through the administration of vitamin K; there is no such antidote for Pradaxa-induced bleeding.
In December, 2011 the U.S. Food & Drug Administration launched a review of Pradaxa in response to bleeding-related injuries. We will keep you updated on all Pradaxa developments domestic and abroad.