Andexxa Recall Announced After FDA Says Risk of Blood Clots and Death Outweigh Benefits

FDA analysis also found that the drug’s promised benefits never seemed to appear, failing to reduce bleeding deaths from Xarelto and Eliquis any more than standard medical care.

Federal drug regulators indicate that Andexxa, which was once seen as a solution for bleeding risks linked to newer blood thinners like Xarelto and Eliquis, carries a risk of blood clots and death that is too high to allow the reversal agent to remain on the market.

The U.S. Food and Drug Administration (FDA) issued an Andexxa safety communication on December 18, announcing that the risks of AstraZeneca’s reversal agent were higher than its benefits, indicating that the company will cease sales and production in the United States today, December 22.

Andexxa Accelerated Approval

Andexxa (andexenet) was approved by the FDA in 2018, under a fast-track review process since the drug was intended to stop uncontrollable bleeding events linked to a new generation of direct oral anticoagulants, including Xarelto and Eliquis. Unlike their older predecessor warfarin, these drugs’ blood thinning effects could not be stopped through the use of vitamin K, and doctors often found themselves in situations where they could not prevent patients from bleeding out.

However, as part of the accelerated approval process, the FDA required AstraZeneca to conduct a postmarketing confirmatory study, known as the ANNEXA-1 trial.

The drug was launched carrying a black box warning for thromboembolic risks, like blood clot, deep vein thrombosis and pulmonary embolism. Now, the FDA says that the outcomes of those marketing studies shows the thromboembolism risks were greater than previously believed, leading attorneys to begin investigating the possibility of Andexxa lawsuits.

The ANNEXA-1 trial consisted of 404 patients, with 204 given Andexxa for bleeds experienced while on a Factor Xa blood thinner, such as Xarelto and Eliquis, and 200 treated with usual care without the reversal agent. In November 2024, the FDA Cellular, Tissue and Gene Therapies Advisory Committee reviewed the findings.

The findings of the trial revealed taking Andexxa more than doubled the risk of thrombosis, or blood clots, with 14.6% of Andexxa patients experiencing clotting, as opposed to 6.9% of patients who underwent standard medical care. Andexxa patients were also more than twice as likely to die than those given standard care, with 2.5% of patients dying on the Andexxa side of the trial, compared to just 0.9% treated via standard care.

According to the data, Andexxa blood clots occurred earlier in treatment, and six patients died during the study due to thromboembolic events, compared to only two patients in the standard care group.

In addition to the risks of Andexxa side effects, the agency also found the benefits of the drug were limited. The FDA’s analysis determined Andexxa use showed no signs of improving neurologic status within 24 hours or cutting overall mortality when compared to the standard treatments.

The FDA safety communication indicates that AstraZeneca submitted a request to voluntarily withdraw Andexxa’s approval “for commercial reasons” with an end to manufacturing and sales scheduled for December 22.

Andexxa Lawsuits

Following the Andexxa recall, product liability lawyers are now investigating potential injury and wrongful death lawsuits for individuals who received the reversal agent and experienced serious blood clot-related complications, including:

• Stroke
• Heart attack
• Pulmonary embolism
• Deep vein thrombosis (DVT)
• Other dangerous blood clots requiring emergency treatment
• Sudden or unexpected clotting shortly after Andexxa was administered
• Death caused by a blood clot or clot-related complication

Lawyers are offering free consultations and claim evaluations to help families determine whether financial compensation may be available through an Andexxa lawsuit, as a result of the drug makers failure to adequately research the side effects and warn about potential risks associated with the reversal agent.

All lawsuits over Andexxa side effects are being investigated on a contingency fee basis, which means there are no upfront costs to hire a lawyers, and no fees or expenses are charged unless a recovery is obtained through an Andexxa settlement or verdict.

The introduction of Andexxa came after more than 20,000 Xarelto bleeding lawsuits were filed against makers of the anticoagulant that the reversal agent was intended to make safer. Following a handful of early bellwether trials, which were held to help gauge how juries would respond to certain evidence and testimony that would be repeated throughout that litigation, a $775 million Xarelto settlement was reached to resolve the majority of the litigation in 2021.

Sign up for more health and legal news that could affect you or your family.