Category: Pharmacology & Therapeutics
Keywords: Andexxa, andexanet alfa, withdrawn, Kcentra, 4F-PCC (PubMed Search)
Posted: 2/11/2026 by Wesley Oliver
(Updated: 2/12/2026)
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Take Home Point: Andexxa (andexanet alfa) was voluntarily withdrawn from the US market effective December 22, 2025, due to safety concerns. 4-Factor Prothrombin Complex Concentrate (4F-PCC/Kcentra) remains the standard of care for reversing apixaban and rivaroxaban in life-threatening bleeding.
Why was it pulled? AstraZeneca, in consultation with the FDA, discontinued the manufacturing and sale of Andexxa after the ANNEXA-I post-marketing trial showed that the drug's risks outweigh its benefits. The trial compared Andexxa to usual care (primarily 4F-PCC) in intracranial hemorrhage and found a significant safety signal:
Clinical Action Items:
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Institutional Note: You may recall that our institution (like many others) never added Andexxa to the formulary. We cited the lack of high-quality survival data and cost-benefit concerns as our primary reasoning. Consequently, this market withdrawal requires no change to our local practice. We will continue to use 4F-PCC as our standard for Factor Xa inhibitor reversal, a practice now validated by the FDA's safety findings.
FDA Safety Communication: Update on the Safety of Andexxa by AstraZeneca. December 18, 2025. Link
