AstraZeneca will end US commercial sales of Andexxa, the reversal agent for certain factor Xa inhibitor anticoagulants, after the US Food and Drug Administration raised safety concerns based on postmarketing data. The FDA said it has received reports of thromboembolic events, including serious and fatal outcomes, in patients treated with andexanet alfa. The company confirmed that Andexxa will no longer be manufactured for or sold in the United States after December 22, 2025. Remaining inventory may be used until depleted.
Andexxa received accelerated approval in 2018 for reversal of rivaroxaban or apixaban anticoagulation during life-threatening or uncontrolled bleeding, with a boxed warning for clotting risk. The FDA said postmarketing evidence, including findings discussed during review of the ANNEXA-I confirmatory trial, showed higher rates of thrombosis and thrombosis-related deaths than usual care, leading the agency to conclude the product’s risks outweigh its benefits. FDA informed AstraZeneca of this position, and the company submitted a request to voluntarily withdraw the biologics license application, citing commercial reasons. Clinicians are expected to follow current guidance, consider alternative reversal strategies, and monitor patients for thrombotic complications when restarting anticoagulation after bleeding events. Hospitals may need to review protocols, formulary decisions, and department stocking plans nationwide.
Why it matters
The withdrawal reshapes emergency bleeding management for factor Xa inhibitors by shifting clinical protocols toward alternative reversal approaches under heightened safety scrutiny.
Source Attribution
Source: Pharmaceutical Technology | Adapted & summarized
Published on: 22 December 2025
Category: Healthcare
Region: USA
