Andexxa was pulled off the market after it was linked to a higher risk of thromboembolic events, blood clots, and death.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Andexxa injury cases in all 50 states. If you or somebody you know was diagnosed with a blood clot or died after being treated with Andexxa, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
What is Andexxa?
Andexxa® (andexanet alfa) is medication that was used to rapidly reverse the blood-thinning effects of Xarelto (rivaroxaban) and Eliquis (apixaban) in patients having life-threatening bleeding emergencies.
FDA Safety Warning for Andexxa
In December 2025, the FDA published a Safety Communication to warn patients and doctors about an increase in thromboembolic events, including serious and fatal outcomes, in patients who were treated with Andexxa for life-threatening bleeding.
What Happened?
The FDA warning came after the ANNEXA-I clinical trial found a doubled risk of thromboembolic events from Andexxa compared to patients who received the usual standard of care.
According to the FDA:
The major safety findings included a “doubling of the rate of thromboses and thrombosis-related deaths at Day 30 in the Andexxa arm compared with usual care.”
Andexxa Linked to Higher Risk of Blood Clots
The clinical trial also found significant increased rates of blood clots and deaths for patients who were treated with Andexxa:
- The rate of thrombosis in the Andexxa group was 14.6% versus 6.9% in patients who received the usual care.
- Andexxa was linked to 6 deaths, vs. only 2 deaths in patients who received the usual standard of care.
- According to the FDA: “Death related to thrombotic events through 30 days occurred in 6 patients (2.5%) in the Andexxa arm compared with 2 patients (0.9%) in the usual care control arm.”
What Are Thromboembolic Events?
Thromboembolic events occur when a blood vessel is blocked by a blood clot that has broken free. It stops blood-flow, which can potentially cause tissue damage and death. They may also be called a venous thromboembolism.
Blood clots can cause two types of life-threatening thromboembolic events:
- Deep Vein Thrombosis (DVT) — This occurs when a blood clot develops in the deep veins, most commonly in the legs.
- Pulmonary Embolism (PE) — This occurs when part of a blood clot breaks off and travels to the lungs. It requires immediate medical attention.
Signs & Symptoms of a Pulmonary Emboslim
Some of the most common signs and symptoms of a pulmonary embolism can include:
- Difficulty breathing
- Faster than normal or irregular heartbeat
- Chest pain or discomfort, which usually worsens with a deep breath or coughing
- Cough or coughing up blood
- Very low blood pressure, lightheadedness, or fainting
Who Sold Andexxa?
Andexxa was developed by Portola Pharmaceuticals, which also developed the blood-thinning drug Xarelto. Andexxa received FDA approval in 2018 under a fast-track approval process. Portola Pharmaceuticals was acquired by Alexion in 2020 and AstraZeneca in 2021. It was pulled off the market by AstraZeneca in December 2025.
How Does Andexxa Work?
Andexxa is a modified form of human factor Xa that binds tightly to factor-Xa inhibitors like Xarelto and Eliquis, which prevents them from blocking the real human factor Xa that is necessary for blood to form blood clots. This is how Andexxa works as a fast-acting “antidote” for Xarelto and Eliquis in patients who are bleeding.
FDA Refuses Full Approval for Andexxa Due To Risks
The FDA granted accelerated approval for Andexxa in 2018 because it was the only antidote to Xarelto and Eliquis. As a condition of approval, the FDA required AstraZeneca to conduct safety studies.
The early safety data was positive, but after 7 years on the market, a clinical trial called ANNEXA-I showed higher rates of blood clots and deaths for patients who were treated with Andexxa rather than the usual standard of care for life-threatening bleeding.
Based on this data, the FDA refused to grant full approval for Andexxa because the safety risks outweighed the benefits. AstraZeneca quickly responded by announcing that it would end U.S. sales of Andexxa.
How Can an Andexxa Lawsuit Help?
Patients who were seriously injured by Andexxa may be eligible to file a lawsuit and seek compensation and justice. The side effects linked to this medication are extremely serious and life-threatening.
If you or a loved one experienced a blood clot, pulmonary embolism, DVT, or died after being treated with Andexxa, our lawyers may be able to help you seek justice for your (or your loved one’s) injuries.
Lawsuits will typically seek compensation for the victim’s pain and suffering, medical expenses, lost income, decreased quality of life, loss of consortium (for a spouse), wrongful death, and other losses.
Do I Have an Andexxa Lawsuit?
The Schmidt Firm, PLLC is currently accepting Andexxa injury cases in all 50 states. If you or somebody you know was diagnosed with a blood clot or died after being treated with Andexxa, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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