Eliquis Blood Thinner’s Misrepresentation and Lack of Antidote

Public Health Watchdog Breaking News
Public Health Watchdog Breaking News

Eliquis is an anticoagulant created by Bristol Myers Squibb Co. and Pfizer Inc. to aid in the prevention of blood clots and stroke. However, lawsuits have emerged with plaintiffs alleging that the drug companies misrepresented the safety of the blood thinner that has shown to, on occasion, cause irreversible bleeding events. Three separate lawsuits were filed at the end of May in New York, by patients who suffered excessive bleeding and found that Eliquis had developed no available antidote to control excessive bleeding, reports Law360.

Eliquis (apixaban) is one of the new-generation anticoagulants, alongside Pradaxa (dabigatran) and Xarelto (revaroxoban). The drug is used to reduce the risk of blood clot and stroke in patients with atrial fibrillation, an abnormal heart rhythm that increases the risk of a blood clot. Eliquis is also prescribed for deep vein thrombosis (DVT) and pulmonary embolism (PE). DVT is when a blood clot forms in one of the veins (usually the legs). PE is when the clot breaks free and becomes trapped in the lungs and is a life-threatening condition.

Allegations Against Eliquis

Plaintiffs allege that the drug manufactures of  Eliquis blood thinner misrepresented the risks by concealing the knowledge of the medication’s shortcomings, such as the lack of a reversal agent for those who experienced an excessive bleeding episode after taking the drug.

“Upon information and belief, defendants concealed and failed to completely disclose their knowledge that Eliquis was associated with or could cause life-threatening bleeding in specific patient populations, and failed to fully identify and convey the risks of use of Eliquis at the same time as other blood-thinning agents, such as aspirin,” the complaint said.

The U.S. Food and Drug Administration (FDA) approved Eliquis in 2012 mostly based on a clinical trial known as Aristotle. The plaintiffs maintain that the approval hinged on these trial that were allegedly conducted by “incompetent and untrustworthy” parties in China. The testing agents were accused of fraud for failing to report a death that occurred during the study, not following up with subjects, making dispensing errors where some subjects allegedly never even received the drug, falsifying records and, overall subpar quality control, according to Law360.

National law firm Parker Waichman LLP has extensive experience and success representing clients in pharmaceutical litigation. Attorneys at the firm are available to answer questions for any individuals seeking legal information for a potential lawsuit.

Lack of Warning on Label

When Eliquis began to be marketed in the United States, its label did not reveal the lack of a reversal agent that competing medications, such as Coumadin (warfarin) have, according to the complaint.

Despite the allegations, Bristol-Myers and Pfizer embarked on an “aggressive marketing campaign” for the treatment and maintained that, unlike with Coumadin, patients who take Eliquis do not need to have their blood levels regularly monitored, do not need to adhere to dietary restrictions, and all patients have the convenience of a set dose of the treatment, reports Law360.

“In the course of these direct-to-customer advertisements, defendants overstated the efficacy of Eliquis with respect to preventing stroke and systemic embolism, failed to adequately disclose to patients that there is no drug, agent, or means to reverse the anticoagulation effects of Eliquis, and that such irreversibility would have life-threatening and fatal consequences,” the filing said.

Plaintiffs said, even after the drug manufacturers became aware of “serious hemorrhaging” in patients, they did not publicize all the information or details of the Aristotle study. Patients are seeking compensatory, economic and punitive damages, prejudgment and post-judgment interest, and costs, Law360 reports.

Newer Blood Thinner Side Effects

These newer drugs including Eliquis, Pradaxa, and Xarelto were first prescribed for knee or hip replacements and for deep vein thrombosis (blood clots in the veins of the legs). They were meant to prevent blood clots from forming and to keep blood blowing smoothly, according to WebMD. Reports of side effects, however, began to emerge including: back pain, bleeding gums, headache, bloody stools, difficulty breathing or swallowing, internal bleeding, pulmonary embolism, heart attack, stroke, and brain hemorrhage, the Mayo Clinic reports.

In 2016, a lawsuit filed against Bristol-Myers Squibb and Pfizer involved a woman from Louisiana who died allegedly from the use of Eliquis. In addition, there were reports of potential serious side effects from use of Eliquis such as brain bleeding, gastrointestinal bleeding, and severe pain.

Legal Information and Advice for Eliquis Users

If you or someone you know has been injured by blood thinning medication, such as Eliquis, you may be eligible for valuable compensation. The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).