When AstraZeneca asserted that their recent Andexxa drug recall had to do with “commercial reasons”, we suggested that there was an Andexxa drug safety issue involved, also, in our December 15, 2025, Drug Injury Watch post, “Andexxa Drug Recall December 2025 Due In Part To Safety Issue That Involves Blood Clots“.
And this December 18, 2025, FDA Safety Communication, “Update on the Safety of Andexxa by AstraZeneca“, seems to provide confirmation:
ISSUE: Since approval, the FDA has received postmarketing safety data on thromboembolic events, including serious and fatal outcomes, in patients treated with Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo). Based on available data, the serious risks including the increase in thromboembolic events are such that the FDA considers the risks of the product to outweigh its benefits. The FDA has communicated this position to AstraZeneca, and the company has submitted a request to voluntarily withdraw the BLA for the product for commercial reasons.
Just over a year ago, we wrote about this Andexxa drug safety issue and the possibility of an Andexxa drug recall in our January 3, 2025, Drug Injury Watch post, “Possible Andexxa Recall After FDA Does Not Approve the Anticoagulant Reversal Drug in December 2024“. We concluded the post by stating that we would 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, Drug Injury Watch post, “Do Andexxa Risks Outweigh Benefits Given Increased Rate of Thrombosis and Thrombosis-Related Deaths?“.
Even before the December 2025 Andexxa drug recall was announced, because of this serious Andexxa drug safety issue, we had been looking at possible Andexxa legal compensation cases for patients who developed a pulmonary embolism (PE) or deep vein thrombosis (DVT), causing them to be hospitalized or resulting in their death. 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.
Here are two important facts about these Andexxa legal compensation cases:
- As seen above, there is an apparent increased rate of Andexxa blood clot side effects, which can lead to DVT and/or PE; and,
- 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 legal compensation cases for people who developed a pulmonary embolism (PE) or deep vein thrombosis (DVT), or the family of those who died while using Andexxa.
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