High Rate Of Thrombotic Events And More Thrombosis-related Deaths Compared To Standard Antidote Treatment

(Posted by Tom Lamb at Drug Injury Watch)

Just about a year ago, we wrote about the possibility of an Andexxa drug recall in this January 3, 2025, article, “Possible Andexxa Recall After FDA Does Not Approve the Anticoagulant Reversal Drug in December 2024“, which we ended by stating that we would continue to watch for more developments concerning Andexxa, including whether its benefits outweigh its risks of blood-clot side effects.

Further, we examined this Andexxa drug safety issue that involves blood clots in advance of a November 2024 FDA Advisory Committee meeting about Andexxa (andexanet alfa), suggesting that it may lead to an Andexxa drug recall, in this November 21, 2024 article, “Do Andexxa Risks Outweigh Benefits Given Increased Rate of Thrombosis and Thrombosis-Related Deaths?“.

Later this month, December 2025, there will be an Andexxa drug recall, as reported in this December 12, 2025, MedPage Today article by Nicole Lou, “Anticoagulant Reversal Drug Pulled From U.S. Market“, from which we get the following:

Andexanet alfa (Andexxa) will officially be taken off the U.S. market this month as an emergency reversal medication for contemporary blood thinners.

“The Biologics License Application for Andexxa has been withdrawn for commercial reasons, effective December 22, 2025,” a spokesperson from drugmaker AstraZeneca said in an email to MedPage Today.

To some, it may come as no surprise that [Andexxa (andexanet)] is leaving the market, as the pricey direct oral anticoagulant (DOAC) antidote had been rejected for traditional FDA approval last year.

“In discussions with the FDA, alignment on a feasible path to convert Andexxa from accelerated to traditional approval in the U.S. could not be reached,” AstraZeneca noted. “As agreed with the FDA, Andexxa will no longer be commercially sold by AstraZeneca in the U.S. after December 22, 2025.”

While AstraZeneca asserts therein that their Andexxa drug recall has to do with “commercial reasons”, this December 2025 MedPage Today article, as we had previously, points out the Andexxa blood-clot side effects issue:

Safety concerns arose as early as 2016’s ANNEXA-4 initial study presentation, however, when outside observers noted a signal of excess thrombotic events among the study’s [Andessa (andexanet)] users. The clotting issue became more apparent with ANNEXA-I showing more thrombotic events (14.6% vs 6.9%) and more thrombosis-related deaths (2.5% vs 0.9%) comparing [Andessa (andexanet)] versus usual care with a prothrombin complex concentrate (PCC).

Even before this December 2025 Andexxa drug recall, we had been looking at Andexxa blood clot cases for patients who developed a pulmonary embolism (PE) or deep vein thrombosis (DVT), causing them to be hospitalized or resulting in their death. Here are some basic facts about these Andexxa drug injury cases seeking legal compensation:

• As seen above, there is an apparent increased rate of Andexxa blood clot side effects, which can lead to DVT and/or PE, as well as clotting-related deaths, compared with a different means to reverse anticoagulation.
• Because there are no warnings in the current Andexxa drug label about an increased risk of blood clot side effects for patients using Andexxa, these drug injury lawsuits would not be filed against patients’ doctors.
• These cases would be filed as Andexxa drug injury lawsuits against AstraZeneca, the responsible pharmaceutical company.

Despite this Andexxa drug recall, we remain interested in investigating possible Andexxa blood clot cases for patients who developed a pulmonary embolism (PE) or deep vein thrombosis (DVT), or the family of those who died while using Andexxa.

For those people, we encourage you to submit an Andexxa Blood Clots Case Evaluation Form online – it is free, confidential, and there is no obligation. Or, if you prefer, call 910-256-2971 to speak directly to attorney Tom Lamb about a possible Andexxa drug injury lawsuit.

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