Eliquis Side Effects and Litigation

Eliquis, also known by its generic name apixaban, is an anticoagulant medication prescribed to reduce the risk of stroke and blood clots in patients with nonvalvular atrial fibrillation, as well as to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE).

This post talks about Eliquis side effects. Every drug has them. But Eliquis has proven to be generally safe and effective.

Our law firm is not involved in any Eliquis lawsuits and attorneys do not believe there are viable causes of action with respect to the side effects of Eliquis.

Eliquis

Eliquis (apixaban) is an oral anticoagulant medication that belongs to the class of drugs called direct factor Xa inhibitors. It is prescribed to help prevent blood clots and reduce the risk of stroke in patients with nonvalvular atrial fibrillation (an irregular heart rhythm). Eliquis is also used to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE).

Eliquis works by inhibiting the action of factor Xa, an enzyme involved in the blood clotting process. By blocking this enzyme, the medication helps prevent the formation of blood clots, which can be dangerous and potentially life-threatening if they travel to critical areas like the lungs, brain, or heart.

It is essential for patients to inform their healthcare providers of all medications they are taking, as Eliquis can interact with several other drugs, increasing the risk of bleeding or reducing the medication’s effectiveness. In addition, individuals with kidney or liver problems may need a dose adjustment or special monitoring while taking Eliquis.

Patients should obviously take Eliquis exactly as prescribed and should not stop taking the medication without consulting their doctor. There are risks of going off of the medicine and they include blood clots or stroke. In fact, in April 2021, Eliquis’s label was updated to include a warning about higher stroke rates in patients transitioning from Eliquis to warfarin. If you are considering changing anticoagulants, it is crucial to discuss this with your healthcare professional.

History of Eliquis

Eliquis (apixaban) is a direct factor Xa inhibitor, which means it works by inhibiting a specific enzyme involved in the blood clotting process. It is used as an anticoagulant to prevent blood clots in patients with certain medical conditions, such as atrial fibrillation, deep vein thrombosis (DVT), and pulmonary embolism (PE).

The development of Eliquis began in the early 2000s as a collaborative effort between Bristol-Myers Squibb and Pfizer. The goal was to create a new generation of anticoagulants that would be safer and more convenient than the existing options, such as warfarin, which required frequent blood monitoring and had numerous food and drug interactions.

In 2007, the first clinical trial of apixaban, called the ARISTOTLE trial, was initiated to evaluate its safety and efficacy. This trial, along with several others, provided evidence supporting the use of apixaban for various indications.

Eliquis was first approved for use in the European Union in 2011 for the prevention of venous thromboembolic events (VTE) in adult patients who had undergone elective hip or knee replacement surgery.

In December 2012, the U.S. Food and Drug Administration (FDA) approved Eliquis for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Later, in 2014, the FDA expanded its approval to include the treatment and prevention of recurrent DVT and PE.

Since its introduction, Eliquis has gained widespread use due to its advantages over traditional anticoagulants like warfarin. These advantages include a lower risk of major bleeding, no need for regular blood monitoring, fewer drug and food interactions, and a more predictable anticoagulant effect.

Eliquis Side Effects

These are the most common Eliquis side effects:

Bleeding: The most common and significant side effect of Eliquis is bleeding. The warnings on this are clear which is one reason why the Eliquis class action went nowhere. Bleeding complications can range from mild, superficial bleeding, such as nosebleeds or gum bleeding, to more severe cases, including gastrointestinal bleeding, intracranial hemorrhage, or hematuria (blood in the urine). Patients should be closely monitored for signs of bleeding, and any unusual bruising, blood in the stool, or prolonged bleeding from cuts should be reported to a healthcare professional immediately. A 2024 study found that

nearly one out of every 50 patients who took the drug developed major bleeding events (but it also showed it really lowered the stroke and blood clot risk for patients with irregular heart rhythms).
Thrombocytopenia: Eliquis can cause a decrease in platelet count, which can contribute to an increased risk of bleeding. Thrombocytopenia can manifest as fatigue, weakness, or easy bruising. Patients should have their platelet count monitored regularly, particularly if they experience any of these symptoms.
Anemia: A reduction in the number of red blood cells (RBCs) can occur as a result of Eliquis use. Anemia can cause symptoms such as fatigue, pallor, shortness of breath, and chest pain. Healthcare providers should monitor patients’ RBC levels and adjust the Eliquis dosage if necessary.
Hypotension: Eliquis may lead to a drop in blood pressure, resulting in symptoms like dizziness, lightheadedness, or fainting. Patients should be cautious when standing up quickly and should report any symptoms of low blood pressure to their healthcare provider.
Gastrointestinal symptoms: Some patients may experience gastrointestinal side effects, such as nausea, vomiting, abdominal pain, or diarrhea. These side effects are typically mild and manageable, but patients should consult their healthcare provider if they become severe or persistent.
Headache: Headaches are a common side effect of Eliquis. They are usually mild and can be managed with over-the-counter pain relievers. However, if a headache is severe, persistent, or accompanied by other neurological symptoms, patients should seek medical attention.
Dizziness: Some patients may experience dizziness while taking Eliquis. This side effect is generally mild and transient, but if it becomes severe or persistent, patients should consult their healthcare provider.
Allergic reactions: In rare cases, patients may experience an allergic reaction to Eliquis. Symptoms of an allergic reaction include rash, itching, swelling, difficulty breathing, or severe dizziness. If any of these symptoms occur, patients should seek immediate medical attention.
Liver function abnormalities: Eliquis has been associated with changes in liver function, including elevated liver enzymes and, in rare cases, hepatitis. Patients should have their liver function monitored regularly, and any signs of liver dysfunction, such as jaundice, dark urine, or abdominal pain, should be reported to their healthcare provider.
Renal function abnormalities: Eliquis is eliminated from the body primarily through the kidneys. Patients with impaired renal function may be at an increased risk for bleeding complications due to the reduced elimination of the drug. Healthcare providers should monitor patients’ renal function, and any signs of kidney dysfunction, such as changes in urine output, swelling, or shortness of breath, should be reported.
Drug interactions: Eliquis may interact with other medications, increasing the risk of bleeding or reducing the effectiveness of the drug. Patients should inform their healthcare provider of all medications

Alternatives to Eliquis

There are several alternative anticoagulant medications available besides Eliquis (apixaban). These options include:

Warfarin (Coumadin, Jantoven): A vitamin K antagonist that has been used for decades as an anticoagulant. It requires regular blood monitoring and dose adjustments, as well as dietary restrictions. Eliquis wins most of the head-to-head battles for which drug is better. But it depends on the patient, of course.
Rivaroxaban (Xarelto): A direct factor Xa inhibitor, like Eliquis, used to prevent blood clots in various conditions, including atrial fibrillation, deep vein thrombosis (DVT), and pulmonary embolism (PE). Again, Eliquis seems like the better drug for most patients.
Dabigatran (Pradaxa): A direct thrombin inhibitor used for similar indications as Eliquis, such as preventing strokes in people with atrial fibrillation, treating and preventing DVT and PE. Once again, Eliquis seems to be the better choice for most.
Edoxaban (Savaysa, Lixiana): Another direct factor Xa inhibitor used to reduce the risk of stroke in patients with atrial fibrillation and for the treatment of DVT and PE.
Heparin: An injectable anticoagulant that works by activating antithrombin, a protein that helps prevent blood clot formation. Heparin is often used in hospitals and for short-term treatment.
Low-molecular-weight heparins (LMWH), such as enoxaparin (Lovenox) and dalteparin (Fragmin): These injectable medications are derived from heparin and have similar anticoagulant effects but require less frequent dosing and monitoring.
Fondaparinux (Arixtra): An injectable factor Xa inhibitor used to prevent and treat DVT and PE.

It is important to consult with your doctor to determine the most appropriate anticoagulant medication based on your specific medical condition, risk factors, and individual needs. Doctors really do tailor treatment options for the patients specific needs.

Eliquis Related Lawsuits

As we alluded to earlier, most lawsuits involving Eliquis are malpractice cases related to stopping and restarting (or not restarting) the anticoagulant in addition to an Eliquis class action lawsuit that did not get off the ground

Eliquis Class Action Lawsuit

These were Eliquis lawsuit a few years back and even an effort at a Eliquis class action MDL claiming Eliquis caused severe, uncontrolled bleeding and other serious complications, and that the manufacturers failed to adequately warn patients and healthcare professionals about the risks associated with the drug.

But an Eliquis MDL did not go very far and Judge Denise Cote (the same judge in the Tylenol class action in 2023) ended the litigation. Judge Cote found that there was implied preemption of any state court claims. Implied preemption is a legal concept that comes into play when federal and state laws conflict. In the context of pharmaceutical litigation, such as the Eliquis lawsuits, implied preemption can be invoked by drug manufacturers to argue that federal regulations, such as those enforced by the FDA, preempt state laws governing product liability and warning requirements.

Bull v. Premier Inpatient Partners – Failure to Restart Medication

There are medical malpractice cases involving the use of Eliquis. A Florida malpractice case from 2021 is a case in point. In Bull v. Premier Inpatient Partners, the plaintiff underwent surgery. He was readmitted with complication. The same doctor performed corrective surgery to address the issue. Following the surgery, the patient’s attending physician restarted the patient’s anticoagulant medication but only for a week. The patient received the medication twice a day until the last dose was given. After that, the patient did not receive the medication for five days.

Another defendant-employed doctor took over as the patient’s attending physician. This doctor was aware of the patient’s medication but failed to notify anyone or enter a new order when the patient stopped receiving the medication. A third doctor also rounded on the patient but did not realize the patient was not receiving the anticoagulant medication. Tragically, the patient suffered a stroke due to a blood clot and underwent a procedure to remove it. As we talked about above, going off Eliquis can increase your risk of stroke.

The plaintiffs hired a malpractice lawyer and filed a lawsuit claiming the doctors negligently did not restart the anticoagulant medication as required. The parties ultimately agreed to a settlement during a mediation conference held before a mediator.

Dean v. Pubix – Medication Error

Let’s take a look at another Florida Eliquis lawsuit, coincidentally again in Florida and again in 2021. In Dean v. Publix Supermarkets, Inc., the plaintiff was discharged from a hospital after being treated for deep vein thrombosis in her legs. Her physician prescribed the anticoagulant Eliquis. The pharmacist at Publix dispensed the prescription at the wrong dosage, causing her injuries. She fired a prescription error lawsuit against Publix and the pharmacist, allegedly suffered permanent injury, scarring, and other damages as a result. This case also ended in a settlement.