Dec 18, 2025 · Since approval, the U.S. Food and Drug Administration (FDA) has received postmarketing safety data on thromboembolic events, including serious and fatal outcomes, in …

Dec 22, 2025 · AstraZeneca has pulled its anticoagulant therapy, Andexxa (recombinant coagulation factor Xa), from the US market after patient fatalities. This follows rising concern from the US Food …

Dec 23, 2025 · AstraZeneca ended U.S. commercial sales of the company’s factor Xa reversal agent (Andexxa) on Monday after FDA issued a safety communication concluding that postmarketing data …

Aug 6, 2025 · Andexxa is used to reverse the effects of anticoagulant medication, which may increase your risk of a blood clot, heart attack, stroke, or death. Watch for symptoms such as chest pain, …

Dec 19, 2025 · The FDA announced that postmarketing safety data on Andexxa (coagulation factor Xa [recombinant], inactivated-zhzo) have revealed an increased risk of thromboembolic events, …

Dec 19, 2025 · AstraZeneca’s Andexxa will be withdrawn due to FDA concerns over serious thromboembolic risks. Read more here.

This web site is intended to help healthcare professionals practicing in the US and AstraZeneca authorized persons find scientifically balanced, evidence-based information about AstraZeneca …

Andexanet alfa, sold under the brand name Andexxa among others, is an antidote for the medications rivaroxaban and apixaban, when reversal of anticoagulation is needed due to uncontrolled bleeding. [7]

Dec 18, 2024 · Andexxa is approved to reverse the effects of direct oral factor Xa inhibitors, such as apixaban and rivaroxaban, in cases of life-threatening or uncontrolled bleeding.

Dec 17, 2024 · The fate of Andexxa is unclear at this stage; the FDA could seek withdrawal of the drug or ask for additional confirmatory data. AstraZeneca told FirstWord that "while discussions with the …