The “breakthrough” blood clot drug Eliquis has been linked to severe and uncontrollable bleeding incidents. Patients have begun filing lawsuits, saying the drug’s approval was based on fraudulent trial results.
With no available antidote to reverse its effects, the new blood thinner Eliquis has been linked to excessive bleeding episodes that may lead to death in the event of an emergency.
While this litigation is currently closed, learn more about current Hernia Mesh lawsuits and Hernia Mesh Settlements.
In crisis situations, physicians regularly administer “antidotes” to patients taking blood thinners, allowing the body’s natural clotting ability to return and preventing uncontrollable “bleeds.” The anticoagulant effects of older, low-cost drugs like warfarin can be effectively reversed through a dose of Vitamin K, or donor plasma if immediate reversal is necessary.
Prior to surgical procedures or after a traumatic accident, these anticoagulant reversal agents save lives every day.
But as with two other “new-generation” blood thinners, Pradaxa and Xarelto, there is currently no reversal agent that can stop Eliquis’ anticoagulant effects. An antidote, developed by Portola Pharmaceuticals in collaboration with Pfizer and Bristol-Myers Squibb, the manufacturers of Eliquis, has recently received FDA approval.
Eliquis patients who suffered severe bleeding events after trauma, along with those who experienced internal bleeding, are now considering legal action against the manufacturers of this life-threatening, irreversible drug.
At least three Eliquis claims have already been filed.
Bringing their claims against both Bristol-Myers Squibb and Pfizer, two widows filed suit in New York on June 18. Alleging the companies failed to warn patients and members of the health community that Eliquis has no available antidote, these women say the blood thinner caused their late husbands’ deaths. One man experienced an “irreversible” brain hemorrhage, according to his surviving wife’s complaint.
One month later, an Alabama man filed his own claim against the manufacturers, accusing them of concealing unfavorable study results in their initial approval application with the FDA. The ARISTOTLE study, upon which Eliquis’ approval was largely based, was shoddily performed by incompetent researchers and failed, among other things, to report subject deaths, he writes.
To learn more about these damning allegations, and the shocking Pharmaceutical Approvals Monthly investigation that uncovered evidence of fraud and data concealment that could call Eliquis’ safety into question, visit our Eliquis Lawsuits page.
In light of the drug’s quickly-growing popularity, and with a release date for Eliquis’ antidote unannounced, many members of the legal community expect numerous lawsuits to follow the three already filed.
Eliquis is an anticoagulant, or blood thinner, manufactured by Pfizer and Bristol-Myers Squibb, the world’s 4th and 15th largest pharmaceutical companies respectively.
Approved in 2012, Eliquis is designed to decrease the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Eliquis’ approval was extended on March 14, 2014, for the prevention of deep vein thrombosis (DVT), a condition in which blood clots form in leg veins, in patients who have had knee or hip replacement surgeries. Ultimately, Eliquis’ approval would also come to encompass patients being treated for DVT and pulmonary embolism (PE), as well as those at risk of recurrent DVT and PE.
The drug’s active ingredient, apixaban, belongs to a class of drugs called “Direct factor Xa inhibitors.” Xarelto, another Direct factor Xa inhibitor, has also been linked to a severe risk of uncontrollable bleeding.
For Pfizer and Bristol-Myers Squibb, Eliquis’ market performance has proven extremely lucrative. In 2014 alone, the drug drew in more than $774 million in sales for both companies, on the back of exponential growth. 36% of Eliquis sales came in the last quarter of 2014, suggesting that the drug’s popularity has only begun to take off.
Direct factor Xa inhibitors like Eliquis knock out an enzyme, factor X, essential to the blood clotting process.
Once a blood vessel is injured, fragmentary blood cells called platelets crowd around the site of injury and literally plug the hole.
After filling the vessel’s ruptured lining, platelets need a way to bind together, so they can’t be carried off by the flow of passing blood. In a process known as secondary hemostasis, platelets release several “coagulation factors,” one of which is factor X.
Factor X is first “activated” to become factor Xa. Thus activated, the new factor Xa is able to split a protein called prothrombin into smaller enzymes known simply as “thrombin.” Thrombin, in turn, transforms proteins that are normally soluble into “fibrin,” a fibrous non-soluble protein that can act like a mesh lining or fabric, linking individual platelets together and covering the rupture in the blood vessel.
Together, this process of discrete transformations is called the “coagulation cascade.”
But Eliquis’ active ingredient inhibits factor X’s ability to become factor Xa, thus stopping the coagulation cascade before it can start. Xarelto works in much the same way. A different anticoagulant, Pradaxa, steps in at a different point in the coagulation cascade, inhibiting thrombin rather than factor X.
With the ability to inhibit coagulation, Xarelto, Pradaxa and Eliquis have been approved to treat patients at a high risk of developing life-threatening blood clots.
This approval was initially limited to patients with atrial fibrillation, an irregular heartbeat that often prevents the organ from pumping blood properly. Unsynchronized electrical signals force the heart’s upper chambers, or atria, to quiver chaotically. Rather than being pumped efficiently down to the ventricles, blood can pool at the base of either atrium and eventually clot.
But when the heart’s rhythm returns to normal, these newly-formed clots can be pumped out toward vital organs. According to Dr. Stuart J Connolly, a cardiovascular researcher in Ontario, as many as 95% of blood clots that reach the heart’s left atrium are pumped to the brain, potentially causing strokes.
Less common, but no less dangerous, is systemic embolism, in which the clot is pumped out toward another part of the circulatory system.
Soon after its initial approval, Eliquis was also approved to reduce the risk of blood clots in patients predisposed to deep vein thrombosis or pulmonary embolism, as well as help dissolve blood clots already present in patients with those conditions.
But Eliquis’ effects don’t simply stop at these life-threatening blood clots. The drug has a systemic, currently irreversible effect on coagulation, meaning trauma or internal hemorrhage are more likely to lead to potentially-fatal blood loss in patients on Eliquis.