Eliquis, Xarelto Bleeding Risks Renewed Amid Andexxa Recall Tied to Stroke, Heart Attack Concerns

Andexxa recall leaves doctors to rely on Kcentra as an off-label reversal agent, despite its lack of effectiveness and blood clot risks.

In the wake of a recent Andexxa recall, patients taking the blood thinners Xarelto and Eliquis have been left without a reliable reversal agent to prevent bleeding events, and must turn to the less effective Kcentra, which carries blood clot risks like those linked to Andexxa.

Andexxa (andexenet) was approved by the U.S. Food and Drug Administration (FDA) in 2018, under a fast-track review process. The rapid approval came as doctors struggled to find ways to stop uncontrolled bleeding events linked to the two new Factor Xa blood thinners.

The drugs were introduced as alternatives to the older anticoagulant warfarin, whose blood-thinning effects can be reversed with Vitamin K. That safeguard does not work for the newer medications, and as patients experienced severe bleeding events that were sometimes impossible to stop, Andexxa was rushed to market with requirements for post-marketing studies.

However, on December 18, the FDA announced that Andexxa was being removed from the market after post-marketing studies revealed the risk of blood clots and pulmonary embolism outweighed the drug’s benefits. Sales of Andexxa ended on December 22, 2025. 

As a result, attorneys nationwide are beginning to investigate Andexxa recall lawsuits for individuals and families who received the reversal agent and subsequently suffered a stroke, heart attack, pulmonary embolism, deep vein thrombosis (DVT), blood clots requiring medical treatment or death caused by a blood clot or clot-related complications.

The Andexxa recall rolls back the clock on Xarelto and Eliquis bleeding risks, strokes and heart attacks. While there are other reversal agents on the market, none of them are considered a good fit for the two drugs.

Vitamin K only works with warfarin and similar drugs. There is also Praxbind (idarucizumab), but that is only considered effective with the blood thinner Pradaxa. That leaves only Kcentra (prothrombin complex concentrate, or PCC), which is an emergency reversal agent only approved for warfarin, but can be used in a pinch off label to treat bleeding caused by Xarelto, Eliquis and Pradaxa. However, research has shown it is unreliable.

Unfortunately, Kcentra is linked to similar blood clot problems as Andexxa, leaving patients at risk of stroke, pulmonary embolism and deep vein thrombosis.

This once again leaves doctors in a bind about treating Xarelto and Eliquis patients. These same concerns led to thousands of product liability lawsuits filed against the drugs’ manufacturers before Andexxa was approved. The lawsuits accused the manufacturers of failing to prioritize patient safety by developing the blood thinners without a safe reversal agent for the inevitable bleeding problems.

Ultimately, about 30,000 Xarelto lawsuits were filed against the drug makers, alleging that users and the medical community were not adequately warned about the risk of problems linked to the drug.

Following a handful of early bellwether trials, which were held before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana to help gauge how juries may respond to certain evidence and testimony, a global Xarelto settlement was reached in March 2019, resolving nearly all claims.

Andexxa Lawsuits

In the wake of the Andexxa recall, product liability lawyers are now investigating injury and wrongful death lawsuits for individuals who were given the reversal agent, resulting in serious 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. Lawsuit investigations focus on allegations that the drug maker failed 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 lawyer, and no fees or expenses are charged unless a recovery is obtained through an Andexxa settlement or verdict.

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