FDA
FDA issues alert after fatal thromboembolic events linked to Andexxa
FDA announced that postmarketing data and results from the ANNEXA-I trial show increased thromboembolic events, including fatal outcomes, in patients treated with Andexxa (coagulation factor Xa, recombinant, inactivated-zhzo). Based on these findings, FDA determined the risks outweigh the benefits and communicated this to AstraZeneca, which has requested voluntary withdrawal of its Biologics License Application and will end U.S. commercial sales by Dec. 22, 2025. Andexxa, initially granted accelerated approval in 2018 for reversal of anticoagulation in life-threatening bleeding, demonstrated a higher incidence of thrombosis and thrombosis-related deaths compared with usual care in the ANNEXA-I trial.
Sources:
(2025, December 18). FDA. Update on the Safety of Andexxa [FDA Safety Communication]. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/update-safety-andexxa
(2025, December 19). FDA. Update on the safety of Andexxa by AstraZeneca: FDA Safety Communication. https://www.fda.gov/safety/medical-product-safety-information/update-safety-andexxa-astrazeneca-fda-safety-communication