Eliquis, also known by its generic name apixaban, is an anticoagulant medication that sees frequent use for preventing stroke in patients with atrial fibrillation.

It’s also FDA-approved to treat and prevent pulmonary embolism and deep vein thrombosis in certain patients. Eliquis is one of a new generation of anticoagulants that started to hit the market in 2010.

Before then, the only anticoagulant that had been approved for preventing stroke in patients with atrial fibrillation was warfarin – and it enjoyed market dominance for several decades.

These new drugs including Eliquis were developed to have certain advantages over warfarin. By design, they would not require constant blood testing and dosage adjustment like warfarin.

But as with other anticoagulants, patients run the risk of suffering Eliquis internal bleeding side effects. It’s an inherent risk associated with anticoagulants: the same anticoagulant effect that prevents stroke also puts patients at risk for episodes of excessive bleeding.

Managing Eliquis Internal Bleeding Side Effects

Compounding this risk is the fact that these new anticoagulants were put on the market without any antidote.

This lack of an antidote can make patients much more vulnerable in cases of internal bleeding or physical injury, or if they end up needing sudden and unexpected surgery.

Warfarin patients had the advantage of being able to control excessive bleeding by administering vitamin K, which reduces warfarin’s anticoagulant effects.

But when Eliquis internal bleeding side effects set in, patients have little choice but to wait them out.

Clinical trials reported that Eliquis internal bleeding side effects happened less frequently than similar side effects associated with warfarin.

However, controversy arose when evidence of clinical mismanagement surfaced, implicating one of the labs that conducted some of those trials.

In these China-based trials, evidence suggested a clinical manager had manipulated trial records to cover up improprieties. Adverse events were reported late or not at all.

Patient data went missing shortly before visits by FDA inspectors. Some trial subjects received an incorrect dosage of medication, or the wrong medication entirely.

In response to the reported improprieties, an FDA reviewer commented that had the agency been aware of these deficiencies earlier, it would not have accepted the application for approval.

New Eliquis Litigation

Given the enhanced risks that accompany the lack of an antidote for these new anticoagulants, Eliquis and the other new drugs have been the subject of a recent wave of litigation that has already resulted in hundreds of millions of dollars in settlements.

At least one Eliquis lawsuit has already been filed, arising out of the death of one Eliquis patient. The patient’s surviving spouse now alleges that manufacturers Pfizer and Bristol-Myers Squibb withheld information about Eliquis internal bleeding side effects from patients and doctors, preventing the patients from making an informed decision about their own care.

She faults the companies for the improprieties uncovered in the clinical trial in China, and she says the companies failed to disclose the mismanagement when they should have. She accuses the companies of improperly promoting Eliquis as a better drug than warfarin without disclosing the lack of an antidote.