Update: Texas Man Claims Eliquis Caused Wife’s Bleeding Death
April 25, 2017 – A wrongful death lawsuit filed last month in the Superior Court of Delaware alleges that Eliquis caused the gastrointestinal bleeding death of a Texas man’s wife less than one month after she began taking the drug. Plaintiff claims that Bristol-Myers Squibb and Pfizer failed to adequately warn about the health risks of Eliquis before bringing it to market, and failed to conduct appropriate clinical trials to ensure the drug’s safety and efficacy.
Eliquis is a blood thinner medication used to treat blood clots in the veins (thrombotic events). The drug is classified as a direct factor Xa inhibitor, and works by blocking the activity of clotting factor Xa, which prevents blood clots from developing or getting worse.
The recommended dosing of Eliquis for most patients is 5mg taken orally twice daily. Eliquis was developed by Pfizer and Bristol-Meyers Squibb, and was approved by the U.S. Food & Drug Administration (FDA) in December 2012.
What’s the Problem?
Similar to the newer generation blood thinner drugs Pradaxa (dabigatran) and Xarelto (rivaroxaban), there is no antidote to stop the blood-thinning effects of Eliquis. Therefore, it is believed that users of the drug may be at risk of developing life-threatening bleeding complications because doctors may be unable to treat these patients when an unanticipated bleed occurs.
Eliquis Side Effects
- Uncontrolled bleeding
- Gastrointestinal bleeding
- Hemorrhagic stroke (brain bleed)
- Intracranial hemorrhage (bleeding in the skull)
- Kidney bleeding
- Rectal bleeding
- Blood clot
- Deep vein thrombosis
Eliquis and Stroke: FDA Warning
In August 2014, FDA required that Eliquis labels include a black box warning (PDF) regarding the stroke risk associated with Eliquis:
WARNING: DISCONTINUING ELIQUIS IN PATIENTS WITHOUT ADEQUATE CONTINUOUS ANTICOAGULATION INCREASES RISK OF STROKE
“Discontinuing ELIQUIS places patients at an increased risk of thrombotic events. An increased rate of stroke was observed following discontinuation of ELIQUIS in clinical trials in patients with nonvalvular atrial fibrillation. If anticoagulation with ELIQUIS must be discontinued for a reason other than pathological bleeding, coverage with another anticoagulant should be strongly considered.”
The acronym F.A.S.T. is an easy way to remember the signs of a stroke. When you spot any of the following symptoms in yourself or someone else, you should call 9-1-1 immediately:
- F – Face Drooping – Does one side of the face droop or is it numb? Ask the person to smile. Is the person’s smile uneven?
- A – Arm Weakness – Is one arm weak or numb? Ask the person to raise both arms. Does one arm drift downward?
- S – Speech Problems – Is speech slurred, garbled or hard to understand? Ask the person to repeat a simple sentence. Is it repeated clearly and correctly?
- T – Time to call 9-1-1 – If you or someone you love is experiencing any of these symptoms, you should call 9-1-1 immediately.
Clinical Trial Data Questioned
An FDA reviewer is questioning claims made by Bristol-Myers Squibb suggesting that Eliquis reduces deaths in patients with a-fib compared to warfarin, according to a watchdog report published in the Journal Sentinel. Reviewer Thomas Marciniak says that key data on more than 300 patients was missing from a clinical trial on Eliquis, and that the missing data made claims that the drug reduces death unreliable.
Has Eliquis Been Recalled?
To date, no recall has been issued for Eliquis, and the drug continues to be prescribed to patients around the country. However, product liability lawsuits have alleged that Eliquis should be pulled off the market until a reversal agent or antidote can be manufactured to stop bleeding events.
Is an Antidote Being Developed?
There is currently no known reversal agent that can stop bleeding in patients treated with Eliquis. However, Portola Pharmaceuticals is currently in the last stages of developing Andexanet alfa, a drug that could serve as an antidote for Eliquis and other Xa factor inhibitors. Andexanet alfa should be available on the U.S. market by mid-2016.
Is There a Class Action?
To date, no class action lawsuit has been filed in the Eliquis litigation. However, our lawyers are reviewing individual complaints for patients who experienced bleeding or other serious side effects after taking Eliquis. If we determine that you have a valid claim, compensation may be available to you to assist with medical expenses, lost wages, pain and suffering, and other damages.
Do I Have an Eliquis Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Eliquis lawsuits. We are handling individual litigation nationwide and currently investigating potential settlements in all 50 states.
Free Confidential Case Evaluation: Again, if you or a loved one was injured by Eliquis, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.