AstraZeneca Faces Lawsuit Over Recalled Andexxa
A plaintiff alleges the blood thinner reversal agent caused a stroke, following the drug's 2025 recall due to clotting risks.
Updated on Oct. 22, 2026 in Stroke
A Texas man is suing AstraZeneca, alleging that the reversal agent Andexxa caused him to suffer a stroke and permanent vision impairment. The drug, which was marketed in the United States starting in 2018, was recalled by the FDA in late 2025 due to elevated blood clot risks.
Why it matters
The FDA removed Andexxa from the market after determining its blood clot risks outweighed its clinical benefits for patients. The ongoing legal action highlights the serious adverse health outcomes that led to the agency's decision to pull the product.
FDA safety findings identified a 14.6% incidence of adverse blood clot effects among Andexxa patients, compared to a 6.9% rate for those on standard treatment. The full extent of health complications associated with the drug continues to be examined through ongoing litigation.
The players
AstraZeneca
A pharmaceutical company that develops treatments for oncology, cardiovascular, renal, and metabolism diseases.
Roger Naumann
A Texas man who is the plaintiff in a lawsuit alleging permanent injury after receiving Andexxa.
The details
AstraZeneca manufactured Andexxa as a reversal agent intended to quickly negate the effects of blood thinners like Eliquis and Xarelto during emergencies. The FDA determined that the drug carried a higher-than-anticipated risk of causing dangerous blood clots, which prompted the complete withdrawal of the product from the U.S. market in December 2025.
Timeline
2018: Andexxa was first approved for use in the U.S.
December 2025: The FDA announced an Andexxa recall.
October 15, 2026: Roger Naumann filed a lawsuit against AstraZeneca.
Health Landscape
The lawsuit follows the pattern set by the 2025 FDA recall of Andexxa by seeking damages for outcomes the agency previously identified as significant risks. This development underscores the regulatory shift that occurred when the FDA determined the drug's safety profile was insufficient.
If you have questions about treatments you previously received for blood thinner reversal, these concerns are worth discussing with your doctor. Being aware of your medical history and specific medications used during past hospitalizations can help you maintain an accurate personal health record.
The takeaway
The FDA's decision to pull Andexxa from the market reflects a re-evaluation of the drug's benefit-to-risk ratio regarding blood clot formation. Patients who are concerned about past treatments should consult their primary physician to review their medical history and current health status.
Further reading
For additional context on how vascular health is managed during emergencies, see our Stroke resources.
Source note: This article includes information reported by AboutLawsuits.
