The blood-thinner medication Eliquis (generic: apixaban) has been linked to reports of severe, potentially irreversible bleeding events including bleeding in the brain, intestinal bleeding, kidney bleeding, deep vein thrombosis (DVT) and death.
Free Confidential Lawsuit Evaluation: If you or a loved one was injured by Eliquis side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
Eliquis is used to prevent blood clots in the veins after a hip or knee replacement surgery. Most people who have these surgeries are less active for a period of weeks or even months while they recover. This can cause blood flow to slow down, which increases the risk of a blood clot.
Eliquis may also be prescribed to prevent stroke and blood clots in patients with atrial fibrillation, or a-fib, which is a type of abnormal heart rhythm. With atrial fibrillation, part of the heart beats irregularly, which increases the risk of blood clots forming, leading to a stroke. Eliquis was developed by Bristol-Meyers Squibb and Pfizer Inc., and was first approved by the U.S. Food & Drug Administration (FDA) in December 2012.
Eliquis, like other newer generation oral anticoagulants (OACs) like Pradaxa and Xarelto, have been linked to an increased risk of uncontrolled bleeding (hemorrhaging). This is because the drug prevents stroke by inhibiting the blood clotting mechanism.
Warfarin, an older anticoagulant in use for over 50 years in the U.S., also prevents blood from clotting, but the drug’s effects can be reversed with a single dose of vitamin K. No such antidote exists with Eliquis, so once bleeding events begin in patients who use the drug, they are difficult if not impossible to stop.
In an August 2014 study published in the Journal of Neurosurgery, the authors concluded that “Despite their convenience, efficacy and lower (brain bleed) risk, a major limitation of the targeted OACs is that there is currently no specific antidote for any of the agents.”
Side Effects of Eliquis
- Uncontrolled bleeding
- Gastrointestinal (GI) bleeding
- Hemorrhagic stroke (brain bleed)
- Intracranial hemorrhage (bleeding in the skull)
- Blood clot
- Deep vein thrombosis
Lawsuits are being filed alleging that Eliquis causes significant bleeding, deep vein thrombosis (DVT), and other serious side effects. Plaintiffs in these cases contend that Pfizer and Bristol-Meyers Squibb failed to adequately warn doctors and patients that there is no antidote to reverse the blood-thinning effects of Eliquis once bleeding begins. Complaints have also been filed on behalf of individuals who died due to complications from uncontrollable bleeding events, allegedly as a result of using Eliquis.
Signs of Internal Bleeding
- Discolored urine (blood in the urine)
- Red or black-colored stool
- Vomiting or coughing up blood
- Frequent nose bleeds or gum bleeding
- Weakness and swelling in the extremities
- Other unusual bleeding
How Often Should Patients Get Their Blood Tested?
Patients taking warfarin typically need their blood tested between once a week and once a month, according to WebMD. Patients who use Eliquis and other newer-generation anticoagulants don’t require as intensive monitoring.
Warfarin works by making the blood less likely to clot by blocking the body’s ability to recycle vitamin K, which it uses to form clots. With less vitamin K circulating, blood takes longer to clot, but patients require regular testing to determine the proper dosage. Eliquis and other new blood thinners don’t affect vitamin K, so constant monitoring isn’t needed.
During clinical trials, Eliquis was found to be equal or more effective than warfarin; however, the new drug is much more expensive. Whereas treatment with warfarin costs only about $4 per month, a typical monthly dose of Eliquis costs about $300.
Eliquis vs. Xarelto
Data from the Aristotle clinical trial indicated that Eliquis was superior in efficacy and bleeding profile compared to standard warfarin therapy. Among patients with atrial fibrillation (a-fib), Eliquis bested warfarin in preventing strokes while also reducing the risk of bleeding by 31%. Additionally, Eliquis cut the risk of death from any cause by 11%, making it the first new anticoagulant to significantly improve mortality.
Eliquis was shown to prevent strokes about as good as Pradaxa and slightly better than Xarelto. Pradaxa demonstrated superior efficacy but not safety vs. warfarin, and Xarelto was non-inferior to warfarin on efficacy and safety.
FDA Reviewer Questions Eliquis Trial Data
FDA reviewer Thomas Marciniak is questioning claims that Eliquis reduces deaths in patients with a-fib compared to warfarin, according to a watchdog report published in the Journal Sentinel. Marciniak says that key data on more than 300 patients was missing from Eliquis clinical trials, and that the missing data made claims that the drug reduces death unreliable.
“I, like most FDA reviewers, would like to conclude that apixaban (Eliquis) is effective in atrial fibrillation — we would like to have alternatives to warfarin,” Marciniak wrote in a 2012 memo. But the data problems “destroy our confidence” that Eliquis reduces death, he concluded.
Lawsuit Filed Over Bleeding Death of Eliquis User
A lawsuit was filed in New York federal court on behalf of a man who allegedly bled to death after taking Eliquis. The complaint alleges that Eliquis is misleadingly marketed as a one-size-fits-all for users, and without adequate warnings stating that there is no antidote for the drug once internal bleeding begins.
Still No Reversal Agent or Antidote to Stop Eliquis Bleeding
Eliquis has been touted for its ease of use compared to earlier blood thinners, but it still has at least one major drawback – the lack of an antidote. In September 2015, it was announced that the European Medicines Agency (EMA) has recommended approval for Praxbind (generic: idarucizumab) to reverse bleeding events with Pradaxa, a direct thrombin inhibitor. However, this drug will not work with Eliquis or any other Factor Xa inhibitors. Portola Pharmaceuticals is in the process of developing Andexanet alfa, a reversal agent for all Factor Xa inhibitors, which should be approved in the U.S. by mid-2016.
Has There Been a Recall?
To date, no recall has been issued for Eliquis in the U.S., nor has the manufacturer updated warnings following reports of bleeding problems. Product liability lawsuits allege that the benefits of the drug do not justify the risks, and that Eliquis should be recalled until an antidote or reversal agent can be developed to stop internal bleeding events.
Do I Have an Eliquis Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Eliquis lawsuits. We are handling individual litigation nationwide and currently investigating potential settlements in all 50 states.
Free Confidential Case Evaluation: Again, if you experienced bleeding or other side effects after taking Eliquis, you should contact our law firm immediately. You may be entitled to a settlement by filing a class action suit and we can help.