Andexxa Recall Lawsuit Investigation

Andexxa lawsuits are being investigated for individuals who suffered serious blood clots or died after receiving the drug, with claims focusing on whether AstraZeneca failed to adequately warn about the increased risk of thrombotic events that ultimately resulted in an Andexxa recall in December 2025.

Andexxa (coagulation factor Xa recombinant, inactivated-zhzo) was granted accelerated approval by the FDA in 2018, as an emergency reversal agent for patients treated with Xarelto (rivaroxaban) or Eliquis (apixaban) who experienced life-threatening or uncontrolled bleeding. The drug was intended to rapidly counteract anticoagulation in critical care settings, and was introduced with a boxed warning for thromboembolic risks.

However, in the years following its approval, a growing number of individuals began experiencing serious side effects from Andexxa, including dangerous blood clots, heart attacks, strokes and clot-related deaths. Postmarketing safety data subsequently raised concerns that the increased the risk of thrombotic events may outweigh any potential benefits provided by the treatment.

After reviewing these reports, the FDA issued a safety communication in December 2025, indicating that the risk-benefit profile no longer justified continued use of the drug. AstraZeneca subsequently confirmed it would withdraw the drug from the U.S. market and end all commercial sales with an Andexxa recall by December 22, 2025.

Lawsuit investigations are now moving forward to determine whether AstraZeneca may be responsible for serious and often fatal Andexxa side effects experienced by patients, due to the failure to adequately warn about the risk of stroke, heart attack, pulmonary embolism, deep vein thrombosis (DVT) and death.

Who May Qualify for an Andexxa Lawsuit?

Individuals may qualify for financial compensation through an Andexxa lawsuit if they received the reversal agent and later experienced a serious blood clot or clot-related complication, including:

• Stroke
• Heart attack
• Pulmonary embolism
• Deep vein thrombosis (DVT)
• Other dangerous blood clots requiring emergency treatment
• Sudden or unexpected clotting shortly after Andexxa was administered
• Death caused by a blood clot or clot-related complication

If you or a family member suffered one of these injuries after receiving Andexxa, you may be eligible to have your case reviewed as part of an ongoing lawsuit investigation.

2025 Andexxa Lawsuit Investigation Updates

• December 18, 2025 Update: The FDA issued a safety communication stating that postmarketing safety data and clinical trial evidence show an increased risk of serious thrombotic events, including fatal outcomes, in patients treated with Andexxa. Based on these findings, regulators concluded that the risks of the drug outweigh its benefits, prompting AstraZeneca to voluntarily request withdrawal of the biologics license application and confirm that U.S. commercial sales of Andexxa will end by December 22, 2025.
• November 21, 2024 Update: The FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee convened to discuss results from the ANNEXA-I trial and the supplemental biologics licensing application submitted by AstraZeneca for Andexxa. During the meeting, committee members reviewed safety and efficacy data as part of the regulatory process to evaluate whether the drug’s clinical benefit was confirmed, a key step preceding later safety actions.

What Is Andexxa?

Andexxa is an intravenous medication used in emergency situations to reverse the effects of certain prescription blood thinners. The drug is administered through an IV infusion by medical professionals in hospital settings when a patient is experiencing life-threatening or uncontrolled bleeding.

The medication was developed for patients taking factor Xa inhibitor anticoagulants, such as rivaroxaban (Xarelto) or apixaban (Eliquis). These blood thinners are commonly prescribed to prevent strokes and blood clots, but they can also carry a risk of severe bleeding. Andexxa was intended to rapidly counteract those blood-thinning effects in emergency situations.

Andexxa works by binding to factor Xa inhibitors in the bloodstream, temporarily blocking their anticoagulant activity. It is typically given as a one-time treatment, sometimes followed by a short continuous infusion, depending on the clinical situation. Use of the drug was generally limited to emergency rooms, trauma centers, and intensive care units, where doctors were responding to events such as intracranial hemorrhage, internal bleeding, or major trauma.

Andexxa Recall Over Thrombotic Events​

On December 18, 2025, the FDA announced an Andexxa recall after concluding that postmarketing safety data and clinical trial evidence showed the drug significantly increased the risk of serious and fatal blood clots. Regulators determined that these risks outweighed any benefit provided by the medication, leading to its withdrawal from the U.S. market in December 2025.

According to the FDA, safety concerns escalated after review of data from the ANNEXA-I trial, which was required as a condition of Andexxa’s accelerated approval. That study showed that patients treated with Andexxa faced substantially higher and earlier clotting risks compared to patients who received usual care.

Andexxa Blood Clot Risks

• More than double the rate of blood clots: Thrombotic events occurred in 14.6 percent of Andexxa patients, compared to 6.9 percent of patients receiving usual care.
• Higher number of fatal clotting events: Six Andexxa patients died from clot-related complications within 30 days, compared to two deaths in the usual care group.
• Earlier onset of dangerous clots: Of the Andexxa patients who suffered a thrombotic event, 53 percent experienced the event earlier, compared to just 6.3 percent of patients in the usual care group.

The FDA stated that this pattern of increased and earlier clotting events was especially concerning given that Andexxa was administered to critically ill patients in emergency settings.

Andexxa Removed From Market

Based on the overall safety data, regulators concluded that Andexxa posed unacceptable thromboembolic risks and issued a safety communication announcing the recall.

AstraZeneca subsequently confirmed it would withdraw Andexxa from the U.S. market and end all U.S. commercial sales by December 22, 2025, as the FDA continues working to keep healthcare providers and the public informed.

Andexxa Side Effect Lawsuits

Andexxa side effect lawsuits are being investigated after postmarketing studies and FDA safety reviews linked the drug to an increased risk of serious thrombotic events.

What Is a Thromboembolic Event?

A thromboembolic event occurs when a blood clot forms and blocks normal blood flow in a vein or artery. When this happens, oxygen delivery to vital organs can be suddenly reduced or cut off, leading to severe and sometimes fatal complications.

Depending on where the clot occurs or travels, a thromboembolic event can affect the brain, heart, lungs, or other critical organs. These events can develop rapidly and often require immediate medical intervention, which is why the FDA treats them as serious safety concerns.

Andexxa Side Effects Under Review

Based on the FDA’s recall and safety findings, lawsuit investigations are focused on the following thrombotic injuries:

• Blood clots (thrombosis): Lawsuits are being reviewed for patients who developed abnormal or dangerous blood clots after receiving Andexxa. FDA-reviewed data showed that Andexxa individuals experienced more than double the rate of thrombotic events compared to those receiving usual care, raising concerns that the drug increased clotting risk rather than preventing harm.

• Stroke: Andexxa stroke lawsuits are being investigated for those who suffered ischemic strokes linked to clot formation after treatment. Clots blocking blood flow to the brain can cause permanent neurological injury, paralysis, or death and were among the serious thrombotic outcomes cited by regulators.

• Heart attack: Lawsuits involving heart attacks are being evaluated for individuals who experienced clot-related blockages in coronary arteries after receiving Andexxa. These events can result in irreversible heart damage or sudden cardiac death and fall within the thrombotic risk profile identified by the FDA.

• Thrombosis-related death: Wrongful death lawsuits are being investigated for families whose loved ones died from clot-related complications after receiving Andexxa. The FDA reported a higher rate of deaths linked to thrombotic events in Andexxa-treated patients than in those receiving usual care, with fatalities occurring within 30 days of treatment.

Symptoms of Serious Blood Clots After Andexxa

Individuals who experienced thrombotic events after receiving Andexxa often showed sudden and severe symptoms that required immediate medical attention. Symptoms reported in cases involving serious blood clots may include:

• Sudden weakness or numbness, especially on one side of the body
• Difficulty speaking, confusion, or sudden vision changes
• Chest pain or pressure
• Shortness of breath or rapid breathing
• Sudden collapse or loss of consciousness
• Severe headache with no known cause

These symptoms may signal a life-threatening clot affecting the brain, heart, lungs, or other vital organs. The FDA has warned that thrombotic events linked to Andexxa can occur shortly after treatment, requiring immediate medical evaluation.

Andexxa Lawsuit Allegations

Current legal investigations into Andexxa focus on whether AstraZeneca failed to protect patients from known and emerging clotting risks associated with the drug. Andexxa lawyers reviewing these cases indicate that potential litigation will center on the following allegations:

• Failure to adequately warn about serious thrombotic risks, including blood clots and clot-related deaths, despite early safety signals and postmarketing reports.
• Delayed communication of escalating safety concerns, including failure to promptly inform doctors and patients about the increased risk of thrombosis identified in ongoing safety monitoring.
• Continued marketing and use of Andexxa after evidence of harm emerged, even as data suggested the drug increased the risk of serious and fatal clotting events compared to usual care.
• Insufficient action following postmarketing safety data, including failure to issue stronger warnings or usage restrictions before the FDA determined the drug’s risks outweighed its benefits.
• Reliance on limited approval standards, allowing Andexxa to remain on the market without confirmed evidence that it improved patient outcomes while exposing patients to increased clotting risks.
• Failure to promptly remove Andexxa from the market, despite accumulating evidence that the drug posed unacceptable thromboembolic dangers.

These allegations are being examined to determine whether patients and families may have viable failure-to-warn and wrongful death product liability claims related to injuries and deaths linked to Andexxa.

Potential Andexxa Lawsuit Compensation

If Andexxa is found to have contributed to serious injury or death, affected patients and families may be eligible to pursue financial compensation through a product liability lawsuit. Future Andexxa recall settlements in these cases may provide financial compensation intended to address the medical, financial, and personal impact of severe clotting injuries linked to the drug.

Potential damages being evaluated in Andexxa lawsuit investigations may include:

• Emergency and hospital care: Costs related to emergency treatment, hospitalization, intensive care, and follow-up medical services required after a thrombotic event.
• Long-term medical complications: Ongoing treatment, rehabilitation, medications, and monitoring for patients who suffered permanent injury from blood clots, stroke, or heart damage.
• Lost income and disability: Wages lost during recovery, reduced earning capacity, or long-term disability caused by clot-related injuries that limit the ability to work.
• Wrongful death damages: Compensation for surviving family members in cases where a loved one died from thrombosis-related complications after receiving Andexxa, including funeral costs and loss of financial support.

Contact an Andexxa Lawyer

Attorneys are currently investigating potential Andexxa lawsuits following the FDA’s recall and market withdrawal of the drug. If you or a loved one received Andexxa and later experienced serious complications or died, you may be eligible to pursue a lawsuit.

Lawyers are offering free consultations, and all cases are handled on a contingency fee basis, which means there are no upfront costs and no legal fees unless compensation is recovered through a settlement or verdict.