Pradaxa Antidote, Praxbind, Only Available in Hospitals. The bleeding risks associated with Pradaxa (dabigatran etexilate) are fairly well known in the United States following a number of serious injury reports and deaths. Pradaxa was approved by the U.S. Food and Drug Administration (FDA) in 2010 and is manufactured by drug maker Boehringer Ingelheim.
Typically, the body forms clots to avoid deadly, uncontrolled bleeding, a process that involves an array of clotting factors. Blood thinners stop clots from blocking the flow of blood that may lead to heart and brain damage in people at risk for heart attack and stroke, including those diagnosed with atrial fibrillation; a birth defect of the heart; deep vein thrombosis (DVT) and a pulmonary embolism involving a DVT that stops blood flow to the lungs; previous heart valve surgery; and pulmonary hypertension (high blood pressure affecting the heart and lungs). Pradaxa is a blood thinner typically prescribed for patients who are diagnosed with atrial fibrillation and who are at a high risk for stroke.
Pradaxa works by inhibiting the body’s clotting mechanism and is meant to improve blood circulation; however, in some cases, patients have experienced serious and life-threatening Pradaxa bleeding events. When this occurs, the body is unable to recover from minor internal bleeding events and some events have required emergency intervention. Patients also allege that the bleeding complications were not appropriately addressed until lawsuits began to be filed against the drug maker.
All blood thinners disrupt the body’s ability to clot blood. For instance, Coumadin (warfarin) blocks the blood clotting factors that rely on vitamin K from forming, but is not prescribed to completely stop blood from clotting as this may result in death. Patients taking warfarin must undergo routine and ongoing monitoring, generally once every two to four weeks, depending on blood test results. Blood tests are conducted to determine how long it takes a patient’s blood to clot using what is known as a prothrombin time test. This test measures the International Normalized Ratio (INR), which reveals an increased risk of uncontrollable bleeding. A low INR indicates increased risks for blood clots. The warfarin dose is adjusted based on INR results. When an uncontrolled bleeding event occurs in a patient taking warfarin, the readily available antidote is vitamin K. Up until recently, warfarin was the only anticoagulant with a readily available reversal agent.
Unlike warfarin, Pradaxa is prescribed in one dose and does not require ongoing testing and dosing adjustments. Because of its convenience, Pradaxa became rapidly popular; however, patients began alleging that the warning label did not fully explain the severity of Pradaxa bleeding events. In 2011, alone, federal regulators received 817 reports of Pradaxa bleeding events; thousands of additional reports were submitted to other databases. In all, there were 3,781 Pradaxa bleeding injuries reported in 2012. Over 500 of the events led to death. By 2011, the FDA had received over 2,300 reports of “serious bleeding events” from patients prescribed Pradaxa. According to a study conducted at the University of Pittsburgh, approximately nine percent of Pradaxa patients experienced major internal bleeding complications when compared to six percent of warfarin patients. Patients also allege that Boehringer Ingelheim failed to warn patients about these sometimes fatal, bleeding events.
For years after its release, there had been no bleeding antidote available in the case of serious and potentially fatal Pradaxa bleeding complications. Recently, Boehringer Ingelheim developed Praxbind (idarucizumab) as a Pradaxa bleeding antidote. Similar to how vitamin K is used to stop internal bleeding in patients taking warfarin, Praxbind may be used to treat patients suffering from Pradaxa bleeding complications. Praxbind was approved in 2015; however, the antidote is only available for use in hospitals; therefore, Pradaxa’s bleeding risk remains. Praxbind was approved though the FDA’s accelerated program and critics have complained that the drug had not been properly evaluated prior to its release in the United States, resulting in numerous internal bleeding incidents.
The product liability attorneys at Parker Waichman LLP have decades of experience representing clients in lawsuits over allegedly defective drugs. The firm continues to offer free legal consultations to individuals with questions about filing a Pradaxa lawsuit.
Ever since Pradaxa’s bleeding risks became well known to the patient population and medical community, there have been numerous Pradaxa lawsuits filed. Many patients affected by Pradaxa bleeding complications have filed legal actions against Boehringer Ingelheim for failing to warn about uncontrollable Pradaxa bleeding events.
Soon after its release, Pradaxa was the focus of over 4,000 lawsuits tied to thousands of adverse event reports; 750 of these involved deaths allegedly associated with Pradaxa. Plaintiffs similarly alleged that the drug caused serious, uncontrollable bleeding side effects, including gastrointestinal bleeding and cerebral hemorrhaging. In 2012, Pradaxa lawsuits were consolidated in a multidistrict litigation (MDL) in federal court in Illinois. The MDL was organized to coordinate pretrial proceedings in the claims related to Pradaxa side effects.
The plaintiffs in these lawsuits similarly alleged that Boehringer Ingelheim, failed to properly warn them that the side effects of Pradaxa may include dangerous and possibly deadly bleeding. Plaintiffs also noted that, at the time that Pradaxa was released to the market, there was no antidote that could reverse Pradaxa’s anticoagulant effect in case of a bleeding episode. The lawsuits were brought by injured patients and by family members of those who had died, allegedly due to uncontrollable Pradaxa bleeding.
Evidence revealed during the MDL revealed that Boehringer Ingelheim was allegedly aware of the risks of internal bleeding associated with Pradaxa, but concealed study results rather than warn the medical community and patients of possibly dangerous Pradaxa side effects. On the eve of the first day of trial, in May 2014, Boehringer Ingelheim agreed to pay approximately $650 million to settle the some 4,000 active claims in that Pradaxa MDL.
After the court approved the Pradaxa settlement, the court relieved the plaintiffs’ steering committee in the MDL of its responsibilities and the court stopped accepting new claims in the MDL; however, the settlement does not prevent new plaintiffs from filing claims for injuries and deaths that were not covered in the 2014 mass settlement. New cases continue to emerge from Pradaxa patients whose claims were not covered by the 2014 settlement.