Vikas Londhe on Andexxa’s Safety Assessment Updates
Vikas Londhe, Chief Editor of Pharmacally.com, shared on LinkedIn:
”FDA Safety Update: Andexxa Risks Outweigh Benefits After Postmarketing Thromboembolic Events—Market Withdrawal Planned
FDA Updates Safety Assessment of Andexxa After Serious Thromboembolic Events.
On December 18, 2025, the U.S. Food and Drug Administration (FDA) issued a safety communication regarding Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo).
The agency has reviewed postmarketing safety data showing an increased incidence of thromboembolic events, including serious and fatal outcomes, in patients treated with Andexxa.
Based on these findings, the FDA now considers that the risks associated with Andexxa outweigh its benefits in its approved use.”
Read the full announcement here.
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