Andexxa Stroke Lawsuit Alleges Blood Thinner Reversal Drug Caused Falls, Vision Problems

Medication was pulled from the market late last year after the FDA determined Andexxa blood clot risks outweighed the drug’s benefits.

A Texas man has filed a lawsuit alleging he suffered a stroke and permanent vision impairment after receiving Andexxa to reverse bleeding caused by the blood thinner Eliquis.

The complaint (PDF) was filed by Roger Naumann in the U.S. District Court for the Southern District of Texas on October 15, naming AstraZeneca, the drug’s manufacturer, as the defendant.

Naumann claims AstraZeneca knew Andexxa side effects posed a serious risk to patients but failed to provide adequate safety warnings, which eventually led to the drug being pulled from the market.

Andexxa Recall

Andexxa (andexenet) was first approved for use in the United States in 2018 as a reversal agent meant to stop the effects of next generation blood thinners, like Eliquis and Xarelto.

The more commonly used older blood thinner, Warfarin, can be reversed with a dose of vitamin K. However, the technique does not work on the newer drugs, which resulted in some doctors being unable to stop patients from bleeding out. Andexxa was promoted as the answer and fast-tracked through the U.S. Food and Drug Administration (FDA) approval process due to the lack of an alternative.

In December 2025, the FDA announced an Andexxa recall after receiving reports indicating Andexxa blood clot risks were much higher than originally anticipated, resulting in deep vein thrombosis, pulmonary embolism and other thromboembolic risks. According to the agency’s findings, 14.6% of Andexxa patients suffered adverse health effects from blood clots, compared to only 6.9% of patients who underwent standard medical treatment.

The FDA ultimately determined that the risks of Andexxa outweighed the benefits. The drug was removed from the market entirely as a result.

In the wake of those findings, patients like Naumann who suffered serious adverse effects after receiving Andexxa to reverse the actions of blood thinners have begun filing lawsuits over the drug’s safety.

Andexxa Stroke Allegations

According to the complaint, Naumann suffered gastrointestinal bleeding following a colonoscopy in October 2024. Because he was taking the blood thinner Eliquis at the time, doctors administered a two-part, high dose of Andexxa on October 18 to reverse the medication’s effects and control the bleeding.

By October 20, the same day he was discharged from the hospital, Naumann claims he began experiencing anemia, dizziness, fatigue, blurred vision and multiple falls. He returned to the emergency room on October 29, where doctors determined he had suffered a stroke that left him with permanent vision problems.

Naumann alleges AstraZeneca failed to adequately warn patients and medical professionals about the risk of dangerous blood clots associated with Andexxa or provide sufficient guidance on how to recognize and manage those complications.

The lawsuit also maintains that AstraZeneca should have recommended regular blood monitoring following Andexxa treatment and provided physicians with instructions for stabilizing and treating individuals who develop blood clots after receiving the medication.

“During the years since first marketing Andexxa in the U.S., Defendant failed to modify the U.S. labeling and prescribing information for Andexxa which disclosed its true risks. Defendant ignored the increased risk of the development of the aforementioned thrombosis injuries associated with the use of Andexxa, but they have, through their marketing and advertising campaigns, urged consumers to use Andexxa despite these risks.”

– Roger Naumann v. AstraZeneca Pharmaceuticals LP et al.

The lawsuit presents claims of strict liability, manufacturing defect, design defect, failure to warn, negligence, breach of warranty, negligent misrepresentation, fraud and violation of consumer protection/consumer fraud laws. It seeks both compensatory and punitive damages.

Andexxa Lawsuits

Naumann’s complaint is among the first Andexxa lawsuits filed over allegations that the blood thinner reversal agent caused a stroke. Product liability lawyers are now investigating additional Andexxa lawsuits on behalf of individuals who suffered serious complications or lost loved ones due to:

• Stroke
• Heart attack
• Pulmonary embolism
• Deep vein thrombosis (DVT)
• Other dangerous blood clots requiring emergency treatment
• Sudden or unexpected clotting shortly after Andexxa was administered
• Death caused by a blood clot or clot-related complication

Lawyers are offering free consultations and claim evaluations to help families determine whether financial compensation may be available through an Andexxa lawsuit, as a result of the drug maker’s failure to adequately research the side effects and warn about potential risks associated with the reversal agent.

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