Johnson//Becker is investigating claims for individuals and their loved ones who used Andexxa and experienced serious complications, negative side effects, or death as a result of the drug.
Studies Show Growing Concerns Over a Correlation Between Andexxa Usage and a Potential Thromboembolic Event
Studies have shown growing concerns regarding the risks associated with Andexxa, such as the increased possibility of experiencing a thromboembolic event. A thromboembolic event takes place in the circulatory system, and includes the chance of developing a blood clot that poses a health and safety risk to the individual in question.
On Dec. 18, 2025, the U.S. Food and Drug Administration (FDA) announced that it had received postmarketing safety data of the use of Andexxa, including a doubling in the overall risk of thrombosis (14.6%) and a doubling in the amount of patients who passed during 30 days of treatment (2.5%.)
Andexxa was developed by Portola Pharmaceuticals and was later acquired by AstraZeneca. It received FDA accelerated approval in 2018 due to the perceived urgent need of a reversal agent due to the anticoagulant effect of certain factor Xa inhibitors including apixaban (Eliquis) and rivoroxaban (Xarelto). AstraZeneca voluntarily removed the product from market use December 22, 2025 due to safety concerns.
Understanding the Connection Between Andexxa and Thromboembolic Events
Following the accelerated approval of Andexxa, the FDA required AstraZeneca to conduct a post marketing study which was named ANNEXA-I trial. AstraZeneca shared those results in early 2024 with the FDA.
- ACEP Now reported in September 2024 that patients in the Andexxa cohort experienced a greater number of both myocardial infarction (heart attack) and ischemic stroke.
- In October 2024 the FDA announced that the Cellular, Tissue, and Gene Therapies Advisory Committee would discuss the findings from AstraZeneca’s ANNEXA-I trial. These results included a more than doubling the risk for both incidents of thrombosis as well as thrombosis-related deaths after treatment with Andexxa versus the usual standard of care.
- The November 2024 meeting resulted in the FDA communicating to AstraZeneca their position of declining to grant Andexxa full approval. AstraZeneca, after receiving the FDAs position, requested to withdraw the product from the market which was announced by the FDA in December 2025.
What is Andexxa?
Andexxa is an anticoagulant reversal agent applied directly into the vein through an injection, and was used to help the body’s natural clotting process to resume. It was only approved for patients taking rivaroxaban or apixaban who had uncontrolled, severe, or life-threatening bleeding as well as to rapidly reverse anticoagulation before emergency surgery in patients on these medications.
What is a Thromboembolic Event?
A thromboembolic event refers to thrombosis, the creation of a blood clot, and embolism, when the blood clot breaks off and travels through the body. The event references the health related outcome that is a result of the clot being released into the blood stream.
Potential Andexxa Side Effects & Complications
The following lists a few of the complications the lawyers at Johnson//Becker are investigating:
- Acute myocardial infarction
- Myocardial infarction
- Cardiac thrombus
- Iliac artery occlusion
- Deep vein thrombosis
- Ischemic Stroke
Do I Qualify to Participate in an Andexxa Lawsuit?
We are pursuing and currently accepting new Andexxa lawsuits for individuals and their loved ones who experienced:
- A blood clot
- Ischemic stroke
- Myocardial infarction (heart attack)
- Pulmonary embolism (lung artery blockage)
- Sudden death
Why Choose Johnson//Becker for Your Andexxa Lawsuit?
Johnson//Becker is dedicated to serving you or your family with care, compassion, and commitment. Our lawyers have significant legal qualifications and over two decades of experience to best represent your interests in matters of injury due to drug side effects such as Andexxa.
Learn More: Why Choose Us
Questions About an Andexxa Lawsuit? Contact a Johnson//Becker Lawyer for a Free Case Review.
If you or a loved one were injured or adversely affected by Andexxa, you may want to speak with the lawyers at Johnson//Becker. We are currently accepting Andexxa lawsuits nationwide, and you may be entitled to financial compensation.
We offer a Free Case Evaluation. Please contact us using the form below or by calling us at (800) 279-6386.
We would be honored to speak with you and respond promptly to every inquiry we receive.
Free Case Evaluation
To contact us for a free review of your potential case, please fill out the form below or call us toll free 24 hrs/day by dialing: (800) 279-6386.