Stuntebeck, from Kentucky, filed a lawsuit on February 18, in the Philadelphia County Court of Common Pleas. Stuntebeck states that she used Xarelto in July 2012, to treat atrial fibrillation. In February 2013, she was hospitalized for several days with severe internal and gastrointestinal bleeding.
Stuntebeck, claims that Johnson & Johnson and Bayer sold an unreasonably dangerous and defective drug, failing to warn consumers and the doctors about the risk of bleeding events that might be “irreversible.”
Xarelto Has No Antidote
Xarelto is one of a newer types of anticoagulants that are touted to be safer and require less monitoring. Unlike warfarin, Xarelto does not have an FDA-approved reversal agent to quickly stop the drug’s blood thinning effects. According to experts, doctors have been using emergency treatments to stop Xarelto’s bleeding side effects, in an attempt to prevent serious injuries and deaths.
Adverse Medical Reports
The German newspaper Der Speigel, in 2013, wrote that 968 adverse events involving Xarelto were reported to German health officials in the first eight months of 2013, including 72 deaths. That compared to 750 events and 58 deaths through all of 2012 in that country.
What is the Problem with Xarelto?
Xarelto (rivaroxaban) is a factor Xa inhibitor inhibitor, which like the newer anticoagulant drugs, are used to reduce the risk of blood clots and strokes. Xarelto inhibits free factor Xa and prothrombinase activity. Xarelto has no direct effect on platelet aggregation, but indirectly inhibits platelet aggregation induced by thrombin. By inhibiting factor Xa, Xarelto decreases thrombin generation, leading to anticoagulant state.
These newer direct thrombin inhibitors and factor Xa inhibiting drugs are heavily marketed, with direct to consumer advertising, as a replacement for Coumadin, or warfarin, which has been the standard anticoagulation therapy for the past 30 years. The direct thrombin inhibitors have been touted as superior to warfarin because they require no blood test monitoring to maintain the correct dose.
Xarelto, Pradaxa and other newer anticoagulants have no reversal agent. Doctors use vitamin K and plasma to reverse any bleeding problems with warfarin. Unfortunately, no antidote is available for the direct thrombin inhibitors. It can be impossible to prevent serious injury or death if patients suffer bleeding problems.
Xarelto and Pradaxa Lawsuits
Pradaxa (dabigatran) manufactured by Boehringer Ingelheim in October 2010, was the first to reach the market. Pradaxa is one of the most common prescription medications with many adverse event reports submitted to the FDA.
Boehringer Ingelheim is exposed to over 2,000 Pradaxa severe bleeding injury lawsuits. The allegations claim that the drug maker failed to warn about the risks associated with Pradaxa, including the lack of an available reversal agent to stop catastrophic bleeding problems. In May, Boehringer Ingelheim paid $650 million to settle thousands of internal bleeding cases involving its blood thinner, Pradaxa.
Recently, the FDA rejected Xarelto use for the treatment of acute coronary syndrome, saying that the drug makers failed to show that the drug was both safe and effective. It was the third time the FDA had refused to expand Xarelto’s approved use.