Patients who choose the anticoagulant Eliquis may be confronted with an increased risk of internal bleeding.

Eliquis is also known by the generic name apixaban. Like other anticoagulants, it’s used to prevent clot-related injuries like deep vein thrombosis and pulmonary embolism.

It is one of a group of new medications recently developed to compete with the older drug warfarin, which has been the go-to anticoagulant for decades. Though warfarin is so well-established, it has certain disadvantages in that it requires regular blood testing and dosage adjustment to get the dosage exactly right.

The new anticoagulants were designed not to require so much maintenance.

Eliquis also sees widespread application in patients with atrial fibrillation to reduce their risk of stroke. With atrial fibrillation, an irregular heartbeat may allow blood to pool in the heart. The stagnant blood may form clots, which can travel to the brain and cause a stroke.

Anticoagulants like Eliquis are often administered to atrial fibrillation patients to reduce the risk of that occurring. About half of the thee million atrial fibrillation patients in the U.S. use anticoagulants for this purpose.

It’s been known for years that anticoagulants like Eliquis provide excellent reduction in stroke risk. But Eliquis side effects also include an increased risk of aggravating any bleeding injury.

That’s the flip side of inhibiting the blood’s natural ability to clot: it also prevents clotting in situations when clotting would be desirable. So when a patient on Eliquis suffers from internal bleeding, Eliquis may make that bleeding difficult or impossible to control.

Compounding that problem for some Eliquis patients has been the fact that the drug was approved for sale despite the lack of an effective reversal agent that could stop its anticoagulant effect.

This factor can complicate things for patients suffering life-threatening internal bleeding like gastrointestinal bleeding or hemorrhagic stroke, or for those who suddenly need emergency surgery that would lead to significant bleeding.

Although Eliquis was designed to have certain advantages over warfarin, its lack of an antidote is one drawback that warfarin does not have. Patients who suffer internal bleeding on warfarin have had the option of administering vitamin K as an antidote.

Some Eliquis patients, then, have taken issue with the way manufacturer Bristol-Myers Squibb has promoted Eliquis as being superior to warfarin despite the fact that no effective reversal agent was available for Eliquis.

Questioning the Clinical Trials for Eliquis

Further complicating Eliquis’s reputation are allegations of impropriety in the conduct of some of the clinical studies used to get FDA approval for the drug. Plaintiffs in some Eliquis lawsuits allege that certain Eliquis clinical trials conducted in China were rife with impropriety.

The FDA stalled the approval process for nine months while it investigated allegations that patients at one clinical trial site were given the wrong medicine, records were altered, and some Eliquis side effects went unreported.  Researchers allegedly lost track of some study participants and failed to report one death.

Plaintiffs in some lawsuits over Eliquis say Bristo-Myers Squibb misled patients and physicians by failing to disclose these irregularities.