Andexxa Recall Lawsuit | 2026 Latest Updates

Patients who received Andexxa may have legal options. They took it to reverse a blood thinner, rivaroxaban or apixaban, before surgery or serious bleeding. Some later had a serious clotting event, such as a stroke, heart attack, or pulmonary embolism. Attorneys are investigating claims against Andexxa’s maker, AstraZeneca, over the drug’s thromboembolic risks after treatment. No lawsuit against AstraZeneca has been confirmed filed, and no class action or multidistrict litigation has formed so far. AstraZeneca ended U.S. sales of Andexxa in December 2025, following the FDA’s safety communication on the drug described below. The topic remains at the attorney-investigation stage.

Latest Andexxa Lawsuit Updates

December 22, 2025: AstraZeneca Ends U.S. Sales of Andexxa

AstraZeneca stopped selling and manufacturing Andexxa in the United States on December 22, 2025. The move confirmed the FDA‘s safety communication about the drug, detailed in the December 18 entry below. Hospitals switched to other reversal options for the blood thinners rivaroxaban and apixaban. Patients treated with Andexxa before the withdrawal may still have a legal claim over their injuries.

December 18, 2025: FDA Concludes Andexxa’s Risks Outweigh Its Benefits

The FDA issued a safety communication concluding that Andexxa’s thromboembolic risks outweigh its benefits [1]. AstraZeneca had asked to voluntarily withdraw the drug’s approval for business reasons rather than a new safety finding. The decision followed years of postmarketing safety data showing blood clots, strokes, and deaths in some patients after Andexxa treatment. No Andexxa lawsuit or MDL had been filed as of September 28, 2026.

November 21, 2024: FDA Advisory Committee Reviews Andexxa Safety Data

An FDA advisory committee met to review results from the ANNEXA-I clinical trial of Andexxa. The trial found thrombosis in 14.6% of Andexxa patients, compared with 6.9% on usual care [2]. Thrombosis-related death within 30 days occurred in 2.5% of Andexxa patients, versus 0.9% on usual care. These findings shaped the FDA’s later withdrawal decision and its December 2025 safety communication.

May 3, 2018: FDA Grants Accelerated Approval of Andexxa

The FDA granted accelerated approval of Andexxa in 2018 to reverse rivaroxaban or apixaban in patients with life-threatening bleeding [3]. That approval carried a boxed warning for thromboembolic risk from the start, the FDA’s safety communication later noted. That warning meant doctors and regulators already knew about a clotting risk in 2018. More than seven years of use followed before AstraZeneca withdrew Andexxa from the market entirely.

What Is Andexxa?

The FDA lists Andexxa, also called andexanet alfa, under the proper name coagulation factor Xa (recombinant), inactivated-zhzo, made by AstraZeneca [4]. It is approved for patients on rivaroxaban or apixaban needing reversal for life-threatening or uncontrolled bleeding. Doctors gave it as a one-time dose, sometimes followed by an infusion, before surgery or during serious bleeding. AstraZeneca has since withdrawn Andexxa from the U.S. market, as covered in the Latest Updates above.

Who May Be Affected?

Patients who took Andexxa before a major surgery or to control serious bleeding, and who later had one of these same clotting events, may have a claim. This includes people who used rivaroxaban or apixaban for a heart or blood condition and needed Andexxa to reverse that anticoagulation. The FDA’s own postmarketing data found more clotting events in Andexxa patients than in patients given other reversal treatments. Some of these events occurred soon after treatment, and others surfaced in the weeks that followed. An individual legal review of your specific medical records and treatment history can confirm whether you have a possible claim.

Reported Injuries or Damages

Postmarketing safety data show thromboembolic events, including serious and fatal outcomes, in some patients treated with Andexxa. These events include stroke, heart attack, pulmonary embolism, deep vein thrombosis, and clot-related death. The same FDA advisory committee review, described above, found a higher rate of thrombosis in Andexxa patients. It also found more thrombosis-related deaths than in patients who received usual care. These are regulator findings from FDA-reviewed trial data. They are not court allegations, since no lawsuit has been confirmed filed. Reports of an injury are not proof that Andexxa caused it. AstraZeneca has not been found liable for any injury, and it has not disputed a claim because none has been filed.

Recall and Regulatory Background

Andexxa has never been the subject of a formal FDA product recall. It is a prescription drug, reviewed under a different process. AstraZeneca ended U.S. sales and manufacturing of Andexxa on December 22, 2025, acting on the FDA’s safety communication described above. The JPML‘s pending-MDL list, current as of July 1, 2026, names no Andexxa or andexanet alfa docket, meaning no case has been consolidated before a single court [5].

Evidence to Preserve

If you believe Andexxa caused a stroke, heart attack, blood clot, or another serious injury, gather and keep the following records:

• Hospital or emergency department records that show when and how Andexxa was given
• Medication administration records and pharmacy records confirming the Andexxa dose you received
• Imaging and laboratory results from around the time of the clotting event
• Records of any follow-up treatment, hospitalization, or rehabilitation you received after the event
• Documentation of related costs, including medical bills, lost income, and travel expenses

Save these records as soon as possible, since hospitals and pharmacies may discard or overwrite them after a period of time.

Filing Deadlines

Deadlines for filing an Andexxa injury claim come from state law, and they are not the same in every state. The filing window depends on where you live and when the injury, or in some states the diagnosis, actually happened. Missing this filing window can end a valid claim entirely, even with strong evidence, so speak with a lawyer promptly.

Potential Compensation

If Andexxa is linked to your injury, potential compensation may include several categories. These include medical expenses, lost wages, pain and suffering, and wrongful-death damages. Compensation amounts vary by case. Past results do not guarantee future outcomes. An individual review can explain what potential compensation might apply to your case.

Frequently Asked Questions

Is There an Official Andexxa Website?

There is no dedicated Andexxa website. Andexxa.com redirects visitors to AstraZeneca’s general U.S. corporate site, astrazeneca-us.com, rather than a standalone product page, so the FDA’s own product listing, cited above, remains the fullest public source on the drug.

What Does the Research Say About Andexxa and Blood Clots?

The research shows Andexxa carries a higher risk of blood clots than other treatments, according to the FDA. In the FDA-reviewed ANNEXA-I trial, 6 of 239 Andexxa patients died from a clot-related event within 30 days. Only 2 of 232 on usual care died the same way.

What Do Doctors Use Instead of Andexxa Now?

Doctors now use prothrombin complex concentrate (PCC) as an alternative to Andexxa for reversing rivaroxaban or apixaban. In the FDA-reviewed ANNEXA-I trial described above, patients not given Andexxa were treated with PCC as usual care.

What Is Andexxa’s Generic Name?

Andexxa’s generic name is andexanet alfa, also listed by the FDA as coagulation factor Xa (recombinant), inactivated-zhzo. Regulators use this full scientific name in official documents, while patients and doctors commonly say Andexxa or andexanet alfa.

What Was the Name of the Andexxa Safety Trial?

The Andexxa safety trial was called ANNEXA-I, a randomized controlled study reviewed by the FDA. Its formal registration number is NCT03661528, and it compared Andexxa with usual medical care for bleeding patients.

Which FDA Committee Reviewed Andexxa’s Safety Data?

The FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee reviewed Andexxa’s safety data on November 21, 2024. This committee typically evaluates biologic products like Andexxa, a recombinant protein rather than a small-molecule drug.

References

1. https://www.fda.gov/safety/medical-product-safety-information/update-safety-andexxa-astrazeneca-fda-safety-communication
2. https://www.fda.gov/media/183674/download
3. https://www.fda.gov/media/113285/download
4. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/andexxa
5. https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_Actions_Pending-July-1-2026.pdf