Like other new anticoagulants, Eliquis has been the subject of many new lawsuits that focus on the risk of bleeding injuries associated with these medications.

All anticoagulants create a risk of excessive bleeding.

It’s a necessary risk associated with the way these drugs function: the same anticoagulant effect that reduces the risk of clot-related injuries also increases the odds of bleeding injuries and makes that bleeding more difficult to get under control.

Reports of Eliquis bleeding injuries have implicated the drug in cases of gastrointestinal bleeding, cerebral hemorrhage, kidney bleeding and rectal bleeding. Some of the more severe cases ended in death.

Symptoms of Eliquis bleeding injuries can vary widely, depending on where the bleeding takes place. A dark, tar-like stool or vomiting blood or a substance that resembles coffee grounds may indicate gastrointestinal bleeding.

Pain or swelling in joints may be a sign of bleeding inside the joint. Bleeding in the brain may be indicated by a headache or dizziness.

FDA Rejects Eliquis Antidote

Compounding the risk of Eliquis bleeding injuries is the lack of an antidote for Eliquis.

Like other new anticoagulants, Eliquis was approved for use in the U.S. even though it does not have an antidote that can reverse its anticoagulant effect in case of emergency.

This lack of an Eliquis antidote remains despite one pharmaceutical company’s attempt to fill the gap.

In August 2016, the FDA rejected an application by pharmaceutical company Portola Pharmaceuticals for approval of andexanet alfa, which was developed to work as an antidote for Eliquis.

After agreeing to give andexanet an expedited review, the FDA issued a rejection letter saying it needed more information about the drug’s manufacturing process.

Portola says it plans to resubmit its application by the end of this year.

Meanwhile, Eliquis users continue to bear the risk of Eliquis bleeding injuries that may not be brought under control using medication.

Litigation Focuses on Eliquis Bleeding Injuries

Plaintiffs in Eliquis lawsuits generally allege that the manufacturers of Eliquis failed to properly warn patients and doctors about the risks of dangerous bleeding associated with the drug, or of the risk that such bleeding injuries could endanger the patient’s life.

They also accuse the manufacturers of failing to disclose flaws in the clinical trials used to gain FDA approval for Eliquis, flaws that were later revealed by FDA investigators.

Personnel conducting the trial were allegedly responsible for instances of failure to report trial results, including side effects and the death of one trial subject.

The makers of Eliquis continued to market the drug despite their knowledge of its associated risks, plaintiffs say.

They allege the companies continue to promote Eliquis as a better alternative to the older anticoagulant warfarin, which unlike Eliquis requires regular blood tests and dosage adjustments.

Plaintiffs also say they were not properly informed about the lack of an antidote before they chose to take Eliquis.

They say the companies’ marketing fails to adequately address the fact that Eliquis has no available antidote – unlike warfarin, which can be counteracted by administering vitamin K.