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by Christopher R. LoPalo, Partner
AstraZeneca has withdrawn Andexxa (andexanet alfa) from the United States market effective December 22, 2025. Patients who experienced adverse health outcomes, complications, or injuries related to Andexxa use may be entitled to compensation.
Andexxa was an emergency medication administered through an IV (intravenously) in hospital settings to reverse the effects of certain blood thinners, including rivaroxaban (Xarelto) and apixaban (Eliquis). It was typically given to patients experiencing life-threatening or uncontrolled bleeding, such as from a brain bleed, major trauma, or internal hemorrhage to stop the blood-thinning medication from working.
Why Was Andexxa Withdrawn?
Andexxa was initially approved in 2018 based on an interim analysis for 227 patients. However, the drug faced significant safety concerns in its clinical trial results, published in 2024, which revealed serious safety issues associated with Andexxa use:
- 10% of Andexxa patients experienced at least one thrombotic event, formed when a blood clot obstructs blood flow, compared with 5.6% of those receiving usual care
- Ischemic stroke, defined as a blockage of blood flow to the brain, occurred in 6.5% of Andexxa patients versus 1.5% in the usual care group
- Heart attack occurred in 4.2% of Andexxa patients versus 1.5% in the usual care group
- Cardiac arrest and other ischemic events were reported
On December 18, 2025, the FDA issued an update, stating that since approval they have received “postmarketing safety data on thromboembolic events, including serious and fatal outcomes, in patients treated with Andexxa,” and that based on available data it “considers the risks of the product to outweigh its benefits.”
Who May Be Affected?
Patients who received Andexxa treatment and subsequently experienced complications may be eligible for compensation, including those who suffered:
- Blood clots or thromboembolic events
- Ischemic stroke, blockage of blood flow to the brain
- Cardiac arrest or heart complications
- Myocardial infarction (heart attack)
- Other serious medical complications
- Additional medical expenses and hospitalization
- Loss of quality of life
Warning signs that you may have experienced Andexxa-related complications include:
- Chest pain or difficulty breathing
- Sudden numbness or weakness
- Severe headache or confusion
- Swelling, pain, or tenderness in the legs
- Any unexpected medical emergency following Andexxa administration
Contact Us Today for a Free Case Evaluation
If you or a loved one received Andexxa and experienced serious complications, kontakt our experienced zespół ds. sporów farmaceutycznych for a free consultation to discuss your legal options.