Various media sources recently announced that an experimental antidote for Pradaxa – an anticoagulant implicated in bleeding deaths – has successfully reversed the effects of the drug in healthy subjects during early trials. One might expect that Pradaxa’s manufacturer, Boehringer-Ingelheim, would be jumping for joy – but the jury is still out. A remedy for serious uncontrolled bleeding brought on by Pradaxa is still sorely needed.
The first of a new generation of anti-coagulants used to prevent strokes in at-risk patients, Pradaxa has been at the center of litigation over deaths due to uncontrolled bleeding. For such patients, even a bump on the head has proven fatal. Doctors prefer Pradaxa and its competitors (Bayer's Xarelto and Eliquis, developed jointly by Pfizer and Bristol-Meyer Squibb) because there are far fewer interactions with other prescriptions than the old standby, warfarin (Coumadin). Patients on these medications therefore require far less in the way of monitoring.
The downside is that while uncontrolled bleeding from warfarin can be reversed by administering high doses of Vitamin K, the only alternative for Pradaxa patients in this situation is emergency dialysis. Allegedly, executives at Boehringer-Ingelheim (BI) knew that there was no quick, reliable way to reverse the effects and failed to issue appropriate warnings.
The new antidote works by preventing Pradaxa (dabigatran) from acting on the Xa (“Ten-A”) factor involved in clotting.
Pradaxa is still outselling its competitors. And, if BI's new antidote ultimately proves effective, it could prove a boon to the manufacturer's bottom line, eliminating worries about the competition. This won't stop the over 1600 pending Pradaxa lawsuits from going forward, however – and it won't stop the number of Pradaxa lawsuits from growing.
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