Pfizer and Bristol-Myers Squibb are facing a wrongful death lawsuit alleging that the companies failed to warn about the risk of irreversible bleeding with Eliquis (apixaban), an anticoagulant. The lawsuit was filed on behalf of a woman whose husband began taking Eliquis to treat his atrial fibrillation in June 2015. According to the lawsuit, he died of internal bleeding less than three months later. Doctors were unable to control the bleeding due to the lack of antidote, the suit states. BMS and Pfizer are accused of failing to warn about the lack of a reversal agent, and the subsequent risk of uncontrollable bleeding.
Atrial fibrillation is a condition caused by an abnormal heart rhythm, leading to an increased risk of blood clots and related injuries, such as stroke. Eliquis was approved in 2012 to treat patients with this condition. Later on, the FDA approved the drug in patients at-risk for pulmonary embolism and deep vein thrombosis. Deep vein thrombosis occurs when a blood clot forms in one of the deep veins of the leg. This can lead to pulmonary embolism, a life-threatening condition, if a piece of the clot breaks off and gets stuck in the lungs.
Eliquis, Pradaxa and Xarelto are part of a newer generation of anticoagulants. The lawsuit alleges that Eliquis and other anticoagulants were marketed as being superior to warfarin. Warfarin has been on the market for decades and requires blood monitoring and dietary restrictions. Patients taking Eliquis and newer anticoagulants do not have these limitations, but the lawsuit alleges that they present a different risk; there is no antidote to stop bleeding if it occurs.
Anticoagulants are meant to reduce the risk of a life-threatening blood clot. However, this also means that there is some risk that the blood won’t clot when necessary. Doctors need to have the most current safety information when assessing a drug’s risks versus its benefits. According to the lawsuit, Eliquis makers did not adequately warn about the lack of an antidote and failed to warn about the risk of irreversible bleeding. It points out that warfarin can be reversed with vitamin K, and asserts that the plaintiff would have taken warfarin if they were fully informed of the risks.
The Cleveland Clinic Journal of Medicine published an article placing Pradaxa, Xarelto and Eliquis in the same risk category, stating that doctors had serious difficulty managing bleeding that occurs in patients taking these drugs.
