As of December 22, 2025, AstraZeneca has officially ceased all production and commercial sales of Andexxa in the United States. This decision followed serious safety warnings from the U.S. Food and Drug Administration (FDA) after a review of the Phase III ANNEXA-I confirmatory study.
The data highlighted a concerning trend: patients treated with Andexxa experienced a 14.6% incidence of thrombotic events, more than double the 6.9% rate observed in the standard care group. Most critically, the study reported multiple fatalities directly linked to blood clots within 30 days of treatment. Consequently, the FDA determined that the drug’s severe risks outweighed its clinical benefits.
Originally granted accelerated approval in 2018, Andexxa served as a reversal agent for patients on specific anticoagulants facing life-threatening bleeding. This voluntary license withdrawal marks the conclusion of its availability in the U.S., even as the drug remains conditionally approved in other regions such as Europe and the UK. AstraZeneca is currently coordinating with healthcare providers to transition to safer alternative treatments for patients in need of emergency coagulation.