AstraZeneca pulled the anti-bleeding medication Andexxa off the market in 2025 due to reports of blood clots and deaths.
Need a Texas Andexxa Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one were injured by blood clots or other side effects of Andexxa, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
What is Andexxa?
Andexxa is a medication that was developed as an “antidote” to two blood-thinning drugs, Xarelto (rivaroxaban) and Eliquis (apixaban).
When these two drugs were approved in 2011 and 2012, they were the first new blood-thinners since warfarin was approved in the 1950s.
But unlike warfarin, which could be deactivated with a simple dose of Vitamin K, there was no simple way to reverse the blood-thinning effects of Xarelto and Eliquis until the FDA approved Andexxa in 2018.
How Does Andexxa Work?
Andexxa was developed by Portola Pharmaceuticals, the same company that developed Xarelto. Xarelto is a blood-thinner that works by blocking a natural substance in the blood called factor Xa, which the body needs to form blood clots.
Andexxa is a modified version of human factor Xa. It is designed to act as a decoy for Xarelto or Eliquis to bind to, essentially mopping up the blood-thinners in the patient’s blood, which frees up the body’s natural factor Xa so that it can create blood clots.
Blood clots are critical to stop bleeding in an emergency situation. The manufacturers of Andexxa hoped that when a patient on Xarelto or Eliquis experienced a bleeding emergency, doctors could administer Andexxa as a fast-acting antidote to deactivate the blood-thinners.
What is the Risk?
Unfortunately, instead many patients who received Andexxa for life-threatening bleeding suffered other serious side effects, such as:
- Blood clots
- Thromboembolism
- Deep Vein Thrombosis (DVT)
- Pulmonary Embolism (PE)
- Other serious thromboembolic events
- Death
Safety Studies Link Andexxa to Higher Rate of Blood Clots
The FDA became aware of the risk of serious blood clots and deaths associated with Andexxa in the first few years on the market. Andexxa was approved under a “fast-track” approval process in 2018, which required the manufacturer to carefully study the risks and benefits.
By 2024, the ANNEXA-I clinical trial showed that patients who received Andexxa had significantly higher rates of thromboembolic events (blood clots) and deaths compared to patients who received the usual standard of care for emergency bleeding. For example:
- Andexxa patients had a thrombosis rate of 14.6% compared to 6.9% in patients who received the usual care for bleeding.
- 6 patients who received Andexxa died, compared to 2 patients who died after receiving the usual care.
- The FDA explained: “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.”
Why Did AstraZeneca Pull Andexxa Off the Market?
Andexxa was pulled off the market in December 2025 by AstraZeneca, the company that acquired the original manufacturers.
AstraZeneca announced its decision to remove Andexxa from the U.S. market by December 22, 2025, after the FDA expressed concerns about findings from the ANNEXA-I clinical trial, which linked Andexxa with significantly higher rates of thromboembolic events and deaths. After the FDA said it would not grant full approval for Andexxa, AstraZeneca made the decision to end commercial sales of Andexxa.
FDA Announces Andexxa Withdrawal From U.S. Market
The FDA published a Safety Communication from AstraZeneca on December 19, 2025:
“Based on available data, the serious risks including the increase in thromboembolic events are such that the FDA considers the risks of the product to outweigh its benefits. The FDA has communicated this position to AstraZeneca, and the company has submitted a request to voluntarily withdraw the BLA for the product for commercial reasons.”
Andexxa Lawsuits
Patients who were injured by side effects of Andexxa may be eligible to seek justice and compensation through a lawsuit. Our lawyers are evaluating cases involving serious side effects like blood clots, thromboembolic events, pulmonary embolism, DVT, and deaths.
How Could a Lawsuit Help?
If you (or a loved one) decide to file a lawsuit for Andexxa injuries, your lawsuit could potentially end in a settlement or compensation for pain and suffering, medical expenses, lost income, wrongful death of a loved one, and other injuries due to severe side effects of Andexxa.
Need an Andexxa Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years of experience, participation in over 600 jury trials, and $260 million in verdicts and/or settlements. Please use the form below to contact our law firm for a free case review.
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: