The anti-stroke drug Eliquis lacks an effective reversal agent, which could lead to severe bleeding in an emergency. A growing number of lawsuits accuse the manufacturers, Pfizer and Bristol-Myers Squibb, of downplaying the risk of uncontrollable bleeding to promote Eliquis as superior to its rivals.
Eliquis Lawsuits Centralized in MDL
In October 2016, lawyers asked judges to centralize Eliquis lawsuits nationwide under one judge in New York. In February 2017, over 50 Eliquis lawsuits were centralized in Multi-District Litigation (MDL No. 2754) in the U.S. District Court for the Southern District of New York under Judge Denise L. Cote. — In re: Eliquis (Apixaban) Products Liability Litigation.
What is Eliquis?
Eliquis (apixaban) is the third member of a new generation of blood-thinning drugs that are designed to prevent blood clots that cause strokes. It is made by Pfizer and Bristol-Myers Squibb and has been approved in the United States since December 2012.
How Does Eliquis Work?
Eliquis works by specifically inhibiting Factor Xa, a key blood clotting protein. This decreases levels of an enzyme called thrombin, which blood cells need to stick together and form clots. It is approved for patients with atrial fibrillation, which is a type of irregular heart rhythm or “flutter” that can cause blood clots.
How Do Blood Clots Form?
After an injury, blood clots plug broken blood vessels to stop bleeding and allow healing. Proteins in the blood called clotting factors (such as Factor Xa) interact and cause red blood cells (called platelets) to stick together. Too much blood clotting can cause life-threatening disorders like heart attack and stroke, but an inability to form clots is dangerous too. Excessive bleeding can occur when patients are on blood-thinning drugs.
Eliquis and Bleeding
Eliquis prevents clots by changing a patient’s blood chemistry. In an emergency, such as after a car accident or before an unexpected surgery, it is essential that any blood-thinning medication is deactivated so that blood clots can form to stop bleeding. The problem with Eliquis is that it had no reversal mechanism when it was approved. Also, the most common serious side effect of Eliquis is bleeding.
Bleeding on Eliquis vs. Warfarin
Advertisements for Eliquis promote it as superior to warfarin (Coumadin), a blood-thinner that can easily be deactivated with a dose of Vitamin K. The ads also claim Eliquis is better than warfarin because it has “less major bleeding than warfarin.” Unfortunately, these ads make no mention of what happens to patients who do start bleeding. If a doctor struggles to deactivate Eliquis, there is a higher risk that the patient will suffer from major complications or bleed to death.
In July 2015, a lawsuit was filed in New York by the widow of a man who died from uncontrollable bleeding. According to the complaint (PDF), drug-makers failed to warn about side effects and used “incompetent and untrustworthy agents in China” to conduct clinical trials.
“No Antidote and Little Clinical Experience”
In June 2013, Prescrire International published a study in which researchers warned there is no treatment with any proven efficacy for stopping severe bleeding on Eliquis. Not even dialysis can remove Eliquis from a patient’s bloodstream. They warned:
“Difficulties in the management of bleeding and of situations in which there is a risk of bleeding weigh heavily in the balance of potential harm versus potential benefit of [Eliquis]. When an oral anticoagulant is required, it is best to choose warfarin.”
FDA Finds Evidence of Fraud in Chinese Clinical Trials
In July 2015, Bloomberg reported that the FDA delayed approving Eliquis for nine months after finding evidence of major fraud and other problems at a Chinese clinical trial site. Documents show that one death went unreported, other “serious adverse events” were concealed, and records were changed or went missing just before the FDA arrived to inspect the trial site in Shanghai — reportedly on the order of a Chinese-based employee of Bristol-Myers Squibb, according to the Wall Street Journal.
Eliquis Bleeding Risks
- Internal bleeding
- Bleeding on the brain (cerebral hemorrhage)
- Intestinal bleeding
- Kidney bleeding
- Uncontrolled bleeding
- Deep Vein Thrombosis (DVT)
- Pulmonary embolism
- Hypovolemic shock
- And more
Eliquis and Hypovolemic Shock
Hypovolemic shock, also known as hemorrhagic shock, is a side effect that occurs when a person loses more than 20% of their blood. It occurs when so much blood is lost that the organs to not have enough to function.
Without blood, organs and tissues do not receive the oxygen and nutrients that need to survive. As they start to shut down, symptoms of shock appear. Both body temperature and blood pressure suddenly drop, which cuts off circulation to vital organs.
Severe cases can lead to death, even with immediate medical attention. Possible complications include:
- Kidney damage
- Brain damage
- Gangrene of arms or legs, sometimes leading to amputation
- Heart attack
- Other organ damage