One of the newest anticoagulant medications available, Eliquis, has already begun to draw legal challenges addressing an increased risk of brain bleed and other hemorrhaging events.

First approved by the Food and Drug Administration (FDA) in 2012, Eliquis is one of a new generation of anticoagulant medications. It’s also known by its generic name apixaban.

Like other anticoagulants, Eliquis is frequently prescribed to reduce the risk of blood clot-related conditions like stroke or systemic embolism in persons who have nonvalvular atrial fibrillation. It is also FDA-approved to treat pulmonary embolism and deep vein thrombosis, and to help reduce the risk of recurrence of those conditions.

But as with anticoagulants in general, the side effects of Eliquis can include an increased risk of potentially life-threatening hemorrhaging, sometimes manifesting as bleeding on the brain.

Eliquis Brain Bleed Lawsuits

Some Eliquis users who suffered bleeding on the brain have already begun to file Eliquis lawsuits. Plaintiffs in these actions have taken issue with one of the clinical studies used to earn FDA approval for Eliquis.

They say that documents from the FDA show that the ARISTOTLE study was tainted with inadequate conduct and oversight. They focus on a trial conducted in China, just one part of the network of over 1,000 different trial sites in 40 different countries.

Allegedly, at one trial site in China, trial administrators altered records to hide violations of trial practice guidelines. Plaintiffs say these administrators failed to report adverse events including one death. Other adverse events were reported late, and some medical outcomes were simply left out of the reported data.

Certain patients received either a double dose of Eliquis or no Eliquis at all, putting them at risk for stroke, the plaintiffs say. Also, some clinical data allegedly went missing before a visit from FDA investigators.

The plaintiff in one Eliquis lawsuit, Lester B. of Alabama, says he was prescribed Eliquis in July 2014 and took it as instructed. Only two days later, he says, he was hospitalized for a type of brain bleed known as an intracranial hemorrhage.

Lester says that before and during the marketing of Eliquis, its manufacturers became aware of several reports of serious hemorrhaging, such as a brain bleed, associated with the use of Eliquis, yet failed to disclose the incidence of those reports to patients or their physicians.

Yet despite the alleged side effects of Eliquis, Lester says the drug has been a significant business success. He says that in 2014, Eliquis sales totaled $774 million, with $281 million of those sales coming from the fourth quarter alone.

Lester says that the labeling and other product information for Eliquis fails to adequately warn its users about the risk of a life-threatening brain bleed and other types of bleeding. He says that had he been properly warned, he would not have purchased or taken Eliquis.

Lester also notes that Eliquis was released onto the market without an antidote that could reverse its anticoagulant effect in case of emergency – unlike the older and more established anticoagulant Coumadin.

Lester filed his Eliquis lawsuit under Case no. 1:15-CV-00379 in the U.S. District Court for the Southern District of Alabama.