Whether physicians are trying to prevent blood clots from forming, or stop existing clots in their tracks, they turn to a standard treatment first: anticoagulants. Traditional blood thinners like heparin and warfarin have proven remarkably effective in most patients since the 1940s.
Every blood thinner naturally carries a risk of excessive bleeding, especially in emergency situations, but the safety of warfarin and heparin is well-demonstrated. And when their effects need to be reversed, several antidotes can effectively restore the ability of a patient’s blood to clot.
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Nonetheless, the announcement of a new generation of blood thinners, with an entirely different mechanism of action, seemed to most doctors like a welcome improvement. In 2012, the American Society of Hematology even felt compelled to ask whether the release of Pradaxa, Xarelto and Eliquis would make warfarin obsolete altogether.
The medical community’s hopes rose to a fever pitch after early reports showed that the new anticoagulants were more effective, and safer than older options.
But unlike warfarin and heparin, the effects of which can be reversed if necessary, the new blood thinners don’t come with an antidote. In the event of an emergency, patients taking Eliquis have suffered severe, irreversible “bleeds,” often with tragic results.
At least three former Eliquis patients have already filed lawsuits, claiming the drug’s manufacturers, Bristol-Myers Squibb and Pfizer, failed to adequately warn the public that Eliquis’ effects couldn’t be reversed.
Two of these claims were filed by widows, survivors who say they lost their husbands to severe bleeding events, including intracranial hemorrhages.
Concerns have also been raised about Eliquis’ potential to result in:
In the American Stroke Association‘s journal Stroke, experts from the University of Texas called intracranial hemorrhage “the most feared and lethal complication of oral anticoagulation.” Their research estimated that patients taking blood thinners are as many as 10 times more likely to experience bleeding inside the brain or within the skull, either as a result of external trauma or internal events like an aneurysm.
Cerebral hemorrhage is a subtype of intracranial, in which blood flows within the brain itself. When blood flows inside the skull, but not inside brain tissue, the hemorrhage is considered “extra-axial.”
The well-known medical term subdural hematoma refers to any collection of blood found outside the brain but within the skull. But around 70% of all blood thinner-related bleeding events in the brain are actually intracerebral hematomas, when blood pools somewhere inside the brain. Some statistics report that 60% of these hematomas within brain tissue are fatal.
Pouring into the space between the brain and skull (a collection of membranes known as meninges), blood can increase the pressure pushing down on brain tissue, potentially crushing the tissue itself or limiting its oxygen supply. At extreme levels, abnormal pressure increases can result in brain herniation; the relatively flexible fat structures of the brain are squeezed across hard surfaces of the skull, becoming misshapen and nonfunctional.
In an aneurysm, the wall of a blood vessel bulges outward, filling like a balloon. When aneurysms rupture, blood spills into surrounding tissues, leading to a condition called hypovolemia, in which the volume of blood available for circulation drops suddenly.
At least one Eliquis lawsuit has been filed in relation to subarachnoid hemorrhage, a type of “extra-axial” hemorrhage that sees blood filling a gap between two layers of the meninges.
When patients with atrial fibrillation (Afib) experience major bleeding events, almost 50% of the excessive bleeds occur in the GI, or gastrointestinal, system.
With a slew of new anticoagulants hitting the market almost simultaneously, the medical community has quickly developed an extensive body of research on their potential risks. Many of the completed studies focus on how blood thinners like Eliquis and Xarelto compare to older treatments like warfarin.
In 2013, a group of gastroenterologists from the Netherlands attempted to pull together more than 43 studies exploring the relationship between new anticoagulants and gastrointestinal bleeding events.
Overall, their meta-analysis suggested that patients taking new blood thinners, including Eliquis, presented a 45% higher risk than warfarin.
Drilling down to analyze the risks of particular drugs, they found that:
Gastrointestinal bleeding is another common cause of hypovolemia, also called hypovolemic shock. Always a medical emergency, if death does not result, risks include systemic organ damage and gangrene in the arms and legs.
Eliquis’ risks may become a reality even in the case of minor injuries. For many patients on anticoagulants, who are already at a higher risk for nosebleeds, even small cuts and bruises can lead to excessive bleeding.
Eliquis’ supposed benefits were “demonstrated” in two large studies, both of which were submitted in support of Bristol-Myers Squibb and Pfizer’s application for FDA approval. But their results have been questioned by many critics, including the US Food & Drug Administration.
In fact, an investigation led by the FDA found that ARISTOTLE, a study out-sourced to Chinese research facilities, was riddled with inaccuracies and blatant data falsification. At least one patient who died after taking Eliquis went unreported, adverse side effects were concealed and many patients taking warfarin were misrecorded as having taken Eliquis. The FDA called it “fraud,” and some experts have gone so far as to question whether Eliquis is any safer or more effective than warfarin.
After the ARISTOTLE study was published in the New England Journal of Medicine (NEJM), Arnold Relman, MD, a former NEJM editor and professor emeritus at Harvard Medical School, went on the attack.
Relman criticized ARISTOTLE’s authors for failing to mention that Eliquis showed no improved benefits over warfarin for almost 40% of the patients studied. Nor, Relman noted, did the study indicate that 35% of the patients on warfarin had received less than clinical doses of the drug. The prominent medical researcher suggested that those low dosages may explain why patients taking warfarin were found at a higher risk of clotting and stroke than people on Eliquis: their blood wasn’t being “thinned” as much.