Eliquis, also known as apixaban, is an anticoagulant medication approved by the FDA to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

It’s also approved to treat and prevent pulmonary embolism and deep vein thrombosis, as well as the prevention of blood clots following hip or knee replacement.

Eliquis is one of a group of relatively new blood thinners that were brought to market to compete with the older medication warfarin, which has been around for decades.

These new drugs have been promoted as being safer and more convenient than warfarin.

Compared to warfarin, these new drugs reportedly cause fewer episodes of major Eliquis bleeding and do not require dietary restrictions or continuous blood testing.

Thanks in part to those selling points, Eliquis has generated high sales figures for manufacturer Bristol-Myers Squibb. Sales last year reached over $1.8 billion.

Concern Over Eliquis Side Effects and Risks

The trouble with Eliquis bleeding is that so far there is no readily available method of Eliquis reversal that would quickly restore normal clotting. Eliquis side effects can include severe bleeding injuries like gastrointestinal bleeding or hemorrhaging in or near the brain.

But since Eliquis first entered the U.S. market in 2012, there has been no antidote available to reverse its effect in cases of major Eliquis bleeding injuries or need for emergency surgery.

Major Eliquis bleeding that occurs during treatment can cause serious long-term problems, and in some cases it could be fatal.

Doctors say they have no particular strategy for Eliquis reversal. They say some doctors, particularly surgeons, dislike the new anticoagulants because of the way they complicate dealing with trauma in a patient who has been taking the new drugs.

New Antidote for Eliquis Bleeding

In December 2015, drug maker Portola Pharmaceuticals applied to the FDA for approval of a possible antidote for Eliquis bleeding. The company says that Andexxa, known generically as andexanet alfa, rapidly reverses the anticoagulant effect of Eliquis.

Approval from the FDA is expected to come sometime in 2016.

The absence of an effective antidote has been a significant problem associated with the new anticoagulants. By one estimate, in the 12 months ending with April 2015, over 50,000 patients were hospitalized in the U.S. with Eliquis bleeding injuries that could have been controlled by administering Andexxa.

Eliquis Bleeding Lawsuits

The risk of uncontrollable bleeding has already been the subject of thousands of legal claims filed against the manufacturers of the other new anticoagulants. More recently, patients have begun filing similar claims over the risk of Eliquis bleeding.

Generally, these plaintiffs are patients who suffered uncontrollable bleeding injuries while taking Eliquis. They argue that Bristol-Myers Squibb knew about the associated risks but concealed that information from both doctors and patients.

Some also take issue with the clinical trials used to get FDA approval for Eliquis. Trials conducted in a particular facility in China got extra FDA attention after reports of significant diversions from good clinical practice guidelines.

Researchers allegedly failed to report certain occurrences of adverse Eliquis side effects. Other instances were allegedly recorded incorrectly. A clinical manager was also accused of falsifying records to cover up flaws in the data.

One FDA reviewer commented that had the agency been aware of the flaws in this study at the time Bristol-Myers Squibb applied for approval of Eliquis, the agency would not have accepted the application.