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If you or a loved one received Andexxa and later experienced a serious clotting complication such as stroke, heart attack, pulmonary embolism, deep vein thrombosis, or a clot-related death, you may be eligible for legal review through an Andexxa Recall Lawsuit.
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Table Of Contents
What’s the Problem?
Andexxa (coagulation factor Xa recombinant, inactivated-zhzo) has been associated with serious thrombotic complications, including stroke, heart attack, pulmonary embolism, deep vein thrombosis (DVT), and clot-related deaths. The same source reports that these concerns contributed to an Andexxa recall and removal from the U.S. market in December 2025 after regulators determined the drug’s overall risk-benefit profile no longer justified continued use.
Andexxa is an intravenous medication intended for emergency reversal of factor Xa inhibitor blood thinners such as rivaroxaban (Xarelto) and apixaban (Eliquis) in hospital and critical care settings when rapid reversal was believed necessary to control severe or uncontrolled bleeding.
Latest Updates
- December 2025 – Regulators concluded Andexxa’s thrombotic risks outweighed its benefits and that AstraZeneca would end U.S. commercial sales by December 22, 2025, after requesting withdrawal of the biologics license application. [1]
Product & Usage Overview
Andexxa was administered by IV infusion in hospital settings for patients experiencing life-threatening or uncontrolled bleeding while taking factor Xa inhibitor anticoagulants. Andexxa was developed to bind factor Xa inhibitors in the bloodstream and temporarily block their anticoagulant activity, typically as a one-time treatment sometimes followed by a short continuous infusion depending on the clinical situation.
Reported Safety Concerns
Andexxa was introduced with a boxed warning acknowledging thrombosis risk, but postmarketing data and follow-up studies later raised concerns that the drug exposed patients to significant thrombotic risk without delivering the expected benefit as a reversal agent.
Injuries & Side Effects
Potential injuries and complications associated with Andexxa as including:
- Stroke
- Heart attack
- Pulmonary embolism
- Deep vein thrombosis (DVT)
- Other blood clots requiring medical treatment
- Clot-related death
Do You Qualify for an Andexxa Recall Lawsuit?
You may want a legal evaluation if:
- You or a loved one received Andexxa in a hospital or emergency setting; and
- You later experienced a serious blood clot or clot-related complication such as stroke, heart attack, pulmonary embolism, DVT, or a clot-related death.
Evidence You Should Gather
If you are evaluating legal options, documentation can be decisive. Consider preserving:
- Hospital and emergency records showing Andexxa administration (date/time, dose, indication).
- Medication administration record (MAR), pharmacy records, and discharge summaries.
- Diagnostic imaging and lab results related to clotting events (as applicable).
- Records of subsequent treatment (ICU notes, cardiology/neurology consults, anticoagulation management, rehabilitation).
- Proof of economic losses (medical bills, time missed from work, caregiver costs, funeral expenses where relevant).
Damages You Can Recover
Recoverable damages depend on state law and the facts of the case, but may include:
- Medical expenses: emergency care, hospitalization, surgery, medications, rehabilitation, and follow-up treatment.
- Lost wages: missed work and diminished earning capacity in severe cases.
- Pain and suffering: physical pain, disability impacts, and emotional distress.
- Wrongful death damages: costs and losses where a clot-related complication resulted in death (availability varies by jurisdiction).
Legal Theories & Liability Grounds
Depending on the evidence, Andexxa-related claims are commonly evaluated under product-liability frameworks, such as:
- Failure to warn: allegations that risks were not adequately disclosed or emphasized for the real-world patient population and use setting.
- Design defect: allegations that the product’s risk profile made it unreasonably dangerous as marketed for emergency reversal use.
- Negligence: allegations related to reasonable care in post-marketing safety surveillance, risk communication, and related conduct.
Statute of Limitations & Timing
Deadlines for filing drug injury claims vary by state and may depend on when the injury occurred and when it was reasonably discovered. If you suspect Andexxa contributed to a serious clotting event, preserving records and seeking legal guidance promptly can help protect your rights.
Frequently Asked Questions
- What is Andexxa used for?
Andexxa is an IV medication used to reverse the effects of certain factor Xa inhibitor blood thinners in emergency bleeding situations. - What complications are being discussed?
Thrombotic complications such as stroke, heart attack, pulmonary embolism, DVT, and clot-related deaths. - What happened in December 2025?
Regulators concluded the risks outweighed the benefits and that U.S. commercial sales would end by December 22, 2025.
Why You Should Act Now
If you believe a serious clotting event occurred shortly after Andexxa administration, preserving hospital records and creating a clear medical timeline can be important. A qualified attorney can review whether the facts support an Andexxa Recall Lawsuit and what documentation is needed to evaluate causation and damages.
References
- https://www.aboutlawsuits.com/andexxa-lawsuit/