There are a lot of similarities between Pradaxa (dabigatran etexilate mesylate), manufactured by Boehringer Ingelheim, and Xarelto (rivaroxaban) by Bayer AG and distributed by Janssen Pharmaceutica, a division of Johnson & Johnson (J&J). Both are anticoagulants marketed as the better alternative to warfarin as the standard therapy for blood clot problems because they do not require stringent monitoring and lifestyle changes. However, they also have no approved agent to reverse the blood thinning effects in case of excessive bleeding, a common problem with anticoagulants, unlike warfarin in which a shot of Vitamin K is an effective antidote. As pointed out on the website of the xarelto lawsuit lawyers Williams Kherkher, patients who take either Pradaxa or Xarelto and who suffer excessive bleeding as a result are at risk of serious injury or death.
There are some differences, though. Pradaxa is part of a class of drugs known as direct thrombin inhibitors and was approved for the treatment of nonvalvular atrial fibrillation (A-fib) by the Food and Drug Administration (FDA) in October 2010, so it had a bit of a head start on Xarelto, gaining approval for the management of atrial fibrillation in July 2011. Xarelto is the first of the direct Factor Xa (10-a) inhibitor class of anticoagulants that act on the Factor X of the coagulation cascade rather than thrombin.
Despite being a latecomer to the US, it wasn’t long before Xarelto surpassed Pradaxa in sales as well as the number of complaints lodged with the FDA. It is a dubious honor, but testament to the popularity of the drug.
The first cases against Boehringer for Pradaxa was filed in March 2012, alleging that the drug maker knew about but failed to warn physicians and patients about the dangers associated with the medication. Xarelto, on the other hand, first came to the civil court’s attention in February 2014, and the claim against Bayer and J&J was that the drug was too dangerous to be administered. Pradaxa is in the midst of multidistrict litigation while only a handful of individual cases have been filed for Xarelto.