Pfizer Inc. and Bristol-Myers Squibb received some good news in October 2014 regarding their leading anticoagulant drug Eliquis (apixaban), which has been at center of several Eliquis lawsuits for allegedly causing uncontrollable bleeding in some patients. The companies are working on an Eliquis antidote that may stop internal bleeding events caused by the medication’s side effects, and reportedly are receiving positive study data.

In a 2014 Phase III study of the FDA-designated breakthrough candidate drug, the drug met its trial goals and was able to immediately reverse the side effects of Eliquis, including internal bleeding. This prospective Eliquis reversal agent, produced by Portola Pharma and known as andexanet alfa, seemed to be well tolerated by the patients participating in the drug’s trials.

According a Portola Pharma representative, “These highly statistically significant Phase III ANNEXA-A data demonstrate that andexanet alfa has the potential to be the first agent approved as a universal Factor Xa inhibitor antidote.” Portola anticipates filing for FDA approval of the Eliquis reversal agent sometime during the year 2015.

Pfizer and Bristol-Meyers are not the only companies who may benefit from an antidote to reverse internal bleeding events resulting from new-generation anticoagulants. Johnson & Johnson and Bayer, the manufacturers of Xarelto, are also hoping this Portola reversal agent will work to control Xarelto bleeding side effects. Boehringer Ingelheim, who designed, manufactured, and sold Pradaxa, is also in Phase III trial tests for its own reversal agent that will hopefully stop Pradaxa internal bleeding events.

It’s expected that whichever company can get their antidote approved and on the market first could gain an edge in the anticoagulant marketing game.

Eliquis Side Effects

Eliquis was first approved by the FDA as a blood thinning treatment in 2012. It has since been commonly prescribed to treat patients suffering from atrial fibrillation or who have recently undergone knee or hip replacement surgery, procedures that make patients vulnerable to strokes and blood clots. One of the main selling points of Eliquis is that the blood thinner allegedly does not require patients to maintain a strict diet and blood monitoring, unlike the more traditional blood thinner Warfarin. However, despite being promoted as safer and superior to Warfarin, Eliquis has allegedly caused many patients to suffer severe internal bleeding side effects.

Similar to claims brought forth in Xarelto and Pradaxa lawsuits, many consumers filing Eliquis lawsuits allege they suffered from uncontrollable internal bleeding and hemorrhaging after taking the drug. Hundreds of patients were allegedly hospitalized because of Eliquis bleeding incidents, some of which have resulted in patient death because the drug lacks a reversal agent to stop the bleeding.

Some commonly reported Eliquis side effects include:

• Bleeding on the brain
• Intestinal bleeding
• Kidney bleeding
• Uncontrolled bleeding
• Deep vein thrombosis (DVT)
• Death

Eliquis lawsuits allege the drug makers negligently manufactured and sold Eliquis without disclosing Eliquis side effects like uncontrollable bleeding risks. The plaintiffs in these Eliquis lawsuits seek monetary compensation for pain and suffering, medical expenses, and other damages related to Eliquis complications.