Dozens of claims over Eliquis and bleeding have been consolidated into a federal multidistrict litigation.

Eliquis, or apixaban, is a product of pharmaceutical companies Pfizer and Bristol-Myers Squibb that entered the market in 2012. It’s approved by the FDA to help reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

It’s also approved to treat pulmonary embolism and deep venous thrombosis, to reduce the risk of their recurrence, and to prevent these conditions in patients who recently underwent hip or knee replacement surgery

Eliquis is the newest of three new drugs that have recently joined the U.S. anticoagulant market. These drugs were developed to offer alternatives to warfarin, sometimes sold under the brand name Coumadin.

Warfarin dominated the anticoagulant market for decades. Since the 1950s, warfarin was the only anticoagulant approved to reduce the risk of stroke that patients with atrial fibrillation faced.

It has its drawbacks, though. Patients taking warfarin have to avoid foods high in vitamin K, which reverses warfarin’s anticoagulant effect. And they also have to submit to regular blood tests to make sure they’re getting an accurate dose.

Eliquis and Bleeding

The new drugs were designed so they wouldn’t have the same drawbacks as warfarin. But one drawback they could not avoid is the risk of excessive bleeding. By impairing blood’s natural ability to clot, these drugs can make bleeding injuries more profuse and sometimes even life-threatening.

The link between Eliquis and bleeding risk becomes even more significant for patients who take certain other drugs that increase the likelihood of bleeding. Aspirin, other anticoagulants, certain anti-inflammatory drugs and some psychiatric medications can all increase the risk of bleeding associated with Eliquis.

Another drawback of Eliquis is that it has no available antidote. Eliquis patients who develop excessive bleeding have no pharmaceutical way to get that bleeding under control.

This lack of an antidote can complicate the treatment of internal bleeding like intracranial hemorrhage and gastrointestinal bleeding. Emergency surgery that could result in heavy bleeding may also have to be delayed until the anticoagulant effect of Eliquis wears off.

The Eliquis MDL

Other new oral anticoagulants have already been the subject of millions of dollars’ worth of products liability litigation. Thousands of patients sued, alleging they were not adequately warned of the bleeding risk associated with these drugs.

A similar volley of claims now appears to be on the way, alleging inadequate warnings about Eliquis and bleeding. There have been only a few dozen such claims filed so far, but more are expected to follow.

In anticipation of this new wave of claims, the federal court system has set up a multidistrict litigation, or MDL, to process these claims together. This MDL will be supervised by U.S. District Judge Denise L. Cote of the Southern District of New York.

An MDL consolidates several similar claims together in the interest of coordinating their pretrial procedures. It can promote more efficient processing and avoid inconsistent judicial rulings.

Previous MDLs against anticoagulant manufacturers drew thousands of individual claims and resulted in hundreds of millions of dollars in settlements. It’s possible the claims over Eliquis and bleeding could multiply to a similar magnitude.