It is often said that modern medicine is a double-edged sword with as much potential to help patients as harm them. The FDA (Food and Drug Administration) has placed strict controls on all proposed drugs but in the case of Pradaxa where the initial results appeared better than any existing anticoagulant, the administration failed to consider its life-threatening risks. After it was approved in 2010 as an answer to the old and difficult to administer anticoagulant Warfarin, Pradaxa (dabigatran) appeared to be the new, ideal blood thinner. While Warfarin was dose-dependent on each patient with an incorrect dosage potentially leading to internal bleeding and other health issues, Pradaxa seemed to be the remedy in its “one pill fits all” form. Boehringer Ingelheim, the pharmaceutical company behind Pradaxa, delivered in its promise to prevent strokes but only months after it was approved, the company was hit with lawsuits for failure to disclose risks. Over 4,000 cases were made against Pradaxa claiming that it caused internal bleeding in patients. While this risk was prevalent with Warfarin, the latter had an antidote to uncontrolled bleeding. Without a cure and hundreds of people dying from its effects, the developers of Pradaxa gave in to the lawsuit in 2011 and agreed to pay 650 million dollars to settle the cases.
In the same year that Pradaxa settled its numerous lawsuits, Xarelto (rivaroxaban) was approved under the intention of preventing clotting in patients that needed lower extremity surgeries. It’s success and decline mirrored that of Pradaxa; it worked as it said it would for a few years but recently, patients began to experience internal bleeding and Janssen Pharmaceuticals, its licensed distributor, could offer neither a remedy to reverse the effects or even remove the drug from the victims’ bodies. While the same risks as Pradaxa have been identified, cases are still mounting against the newly introduced Xarelto.
October 19th marked an important day for patients and victims of Pradaxa alike. Bohelinger Ingelheim released a reversal agent approved by the FDA to isolate and manage uncontrollable bleeding caused by Pradaxa. This antidote, aptly named Praxbind (idarucizumab), once injected will serve its function as an antibody by binding to dabitagran and neutralizing it. Although Praxbind is not without side effects, headaches, low potassium levels, confusion, constipation, fever, and pneumonia seemed a small price to pay to cure the effects of Pradaxa. While it is on an accelerated approval program due to its proven clinical benefits, Praxbind will need still need to deliver consistent clinical results in the next few months. The antidote seems to be the answer to a slew of risks associated with Pradaxa and Xarelto but patients should make all efforts to consult a doctor and even a second opinion if they are prescribed either medications.
If you or a loved one have been negatively affected by Pradaxa or Xarelto, consult your doctor immediately for updates before changing any medication routines and call your personal injury lawyers at Amerio Law Firm to help you get through this tough time.