Update: ISMP QuarterWatch Links Xarelto to 15,000 Adverse Event Reports in 2016
July 18, 2017 – Xarelto was linked to at least 15,043 adverse event reports last year, according to the latest ISMP QuarterWatch Report. A total of 21,996 injuries were associated with the entire class of blood-thinners, nearly 70% of which were tied to Xarelto.
What is Xarelto?
Xarelto (rivaroxaban) is an orally-administered, once-daily medication that is used to prevent blood clots. It was developed by Bayer HealthCare and Johnson & Johnson (J&J) and initially approved in July 2011 by the U.S. Food and Drug Administration (FDA).
Approved indications for Xarelto include:
- Prevention of lower-limb blood clots and deep vein thrombosis (DVT) in patients recovering from hip or knee replacement surgery
- Prevention of strokes in people with atrial fibrillation, a type of irregular heart rhythm that can cause blood clots to form in the heart (approved in November 2011)
Xarelto Bleeding Risks
Bleeding is the most common side effect of Xarelto, which is normal for a blood-thinning medication. However, unlike other blood-thinners, the outcome for Xarelto patients who start bleeding may be very different. Emergency room physicians have over 50 years of experience treating bleeding with Coumadin (warfarin), which can be easily de-activated with a dose of Vitamin K.
Unlike warfarin, Xarelto has no reversal agent or antidote. Furthermore, drug-makers have never conducted clinical trials or developed protocols for treating emergency bleeding in a Xarelto patient. Not even dialysis (removing and mechanically cleaning a patient’s blood) can de-activate Xarelto, because it binds so tightly to plasma proteins.
Black Box Warning for Xarelto and Stroke
Xarelto is a once-daily medication that must be taken every day at the same time. Patients who accidentally miss doses of Xarelto rapidly lose protection against blood clots, which significantly increases their risk of stroke. The Prescribing Information carries a “Black Box” warning about the risk of prematurely discontinuing Xarelto.
Study of Xarelto of Bleeding Risks
Dr. Partha Sardar of New York Medical College presented a study of Xarelto bleeding risks at the American Heart Association 2013 Scientific Sessions. The analysis was based on 48 clinical trials of blood-thinners, including Xarelto, Pradaxa, and more.
Although Xarelto was associated with a lower risk of bleeding in patients with venous blood clots or pulmonary embolism, there was a “four-times higher risk of major bleeding in the setting of ACS and a nearly threefold higher risk of bleeding in the setting of acutely ill patients.”
Xarelto and Blood Clots
When Xarelto fails to protect a patient against blood clots, the consequences can be deadly. In October 2012, the Institute for Safe Medication Practices (ISMP) published a QuarterWatch report after finding that blood clots (pulmonary, venous, and other thromboembolisms) were the predominant adverse event associated with Xarelto, with 158 cases in the first quarter of 2012. The primary complaint for Xarelto is a lack of efficacy, especially for younger patients:
“The largest group of rivaroxaban cases described the development of severe blood clots in younger patients (median age 66) taking the anticoagulant drug after hip or knee replacement surgery.”
Xarelto Side Effects
- Blood clots
- Pulmonary Embolism (PE)
- Deep Vein Thrombosis (DVT)
- Major bleeding requiring blood transfusions
- Surgical bleeding that requires re-operation
- Internal bleeding in critical organs
- Gastrointestinal and rectal bleeding
- Cerebral hemorrhage (bleeding in the brain)
- Heart attack
- Esophageal ulcers
- Kidney failure
Has Xarelto Been Recalled?
In October 2014, a recall was issued for about 13,500 bottles of Xarelto over potential bacterial contamination. Janssen said the contaminated bottles were produced at its Puerto Rico plant – one of 4 facilities the company has since paid millions to upgrade. The Xarelto recall was limited to this isolated incident, and the drug remains on the market.
Xarelto Settlement Information
The first Xarelto bleeding lawsuits were filed in early 2014, and trial dates are scheduled to begin in mid-2016. To date, there have been no reports of the manufacturers agreeing to settle any cases. However, our lawyers are confident the companies will ultimately have to pay substantial compensation to injured parties.
Bayer, J&J Misrepresented Xarelto Risks, Lawsuits Claim
July 12, 2017 – Two men from New York have filed separate lawsuits against Bayer and Janssen Pharmaceuticals alleging that Xarelto caused “life-threatening bleeding” and “other severe and personal injuries.” Plaintiffs Thomas Walsh and Joseph Roman further allege that Bayer and Janssen hid their knowledge of these “serious and dangerous side effects,” including life-threatening bleeding events, which were caused by a lack of adequate clinical trials and studies.
First Xarelto Trial Kicks Off in New Orleans
April 24, 2017 – The first of 4 bellwether trials alleging bleeding side effects from Xarelto is now underway in Louisiana federal court. The complaint was filed by Joseph Boudreaux, who claims he experienced severe internal bleeding less than a month after taking Xarelto for the first time. His injuries required a week-long stay in an ICU, numerous blood transfusions and heart procedures, according to the lawsuit.
Xarelto Bellwether Trials Begin in Louisiana
April 4, 2017 – Judge Eldon Fallon is set to begin hearing the first Xarelto bellwether trials later this month, and the cases are being watched very closely as outcomes could help to determine future rulings. The first trial is scheduled to begin on April 24, with another beginning each month until July. Since the cases involve complex pharmaceutical litigation, each trial could last up to 8 weeks before a jury returns a verdict.
Xarelto Linked to Increased Risk of Bleeding, Mortality Compared to Pradaxa
October 7, 2016 – Xarelto may pose an increased risk of serious bleeding compared to Pradaxa (dabigatran) in patients with an abnormal heartbeat known as atrial fibrillation (a-fib), a new study published in JAMA Internal Medicine has found. Researchers found little difference in the stroke risk among patients treated with either drug; however, there was a small yet statistically significant increase in risk of bleeding in the brain and stomach of patients who used Xarelto. Additionally, in patients 75 and older, Xarelto was associated with a small but statistically significant increased risk of death.
Do I have a Xarelto Class Action Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Xarelto lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free Confidential Case Evaluation: Again, if you or a loved one was injured by Xarelto, you should contact our law firm immediately. You may be entitled to compensation by joining a class action suit and we can help.