Update: 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 (generic: rivaroxaban) is an anticoagulant (blood thinner) medication that prevents the formation of blood clots. The drug is commonly used to prevent a type of blood clot called deep vein thrombosis (DVT), as well as in patients with atrial fibrillation (a heart rhythm disorder) to lower the risk of stroke caused by a blood clot. Xarelto was first approved by the U.S. Food & Drug Administration (FDA) on July 1, 2011; the drug is manufactured by Bayer and marketed by Janssen Pharmaceuticals (a Johnson & Johnson company).
What’s the Problem?
Unfortunately, Xarelto has been linked to hundreds of reports of severe, uncontrolled bleeding — a dangerous and potentially deadly side effect for which there is no antidote. Plaintiffs who claim they were harmed by the drug and family members who lost loved ones have filed lawsuits against Bayer, alleging the company failed to warn them and manufactured a defective drug.
Xarelto Side Effects
Xarelto has been linked to the following serious side effects:
- Internal bleeding
- Blood clots
- Brain hemorrhage
- Epidural hematoma
- Gastrointestinal bleeding
- Pulmonary embolism
- Severe allergic reactions
Other, less severe side effects of Xarelto may include:
- Bloody or black, tarry stools
- Coughing up blood
- Dark urine
- Sore throat
- Pain or new drainage at wound sites
- Pink or red urine
- Red, swollen, blistered, or peeling skin
- Stiff, sore, hot, or painful joint
- Unexplained swelling
- Unusual or prolonged bruising or bleeding
- Vomit that looks like coffee grounds
- Yellowing of the skin or eyes (jaundice)
- And more
No Antidote for Xarelto Bleeding
While there is a risk of bleeding with all anticoagulant medications, Xarelto is more dangerous because there is no antidote or reversal agent for the drug once bleeding starts. Dialysis is also ineffective for flushing the drug out of the system. Warfarin, on the other hand, may also cause bleeding, but these events can be reversed with a single dose of vitamin K.
Bleeding Risk Increased in Acutely Ill Heart Patients: Study
A November 2013 study published in Medscape found a link between Xarelto and a nearly 3-fold increased risk of bleeding in acutely ill patients, as well as a 4-fold increased risk of major bleeding in patients with acute coronary syndrome. The results were based on data from 48 randomized clinical trials involving Xarelto, Pradaxa, Eliquis, Lixiana and darexaban. The researchers wanted to study how the drugs performed against each other, as well as how they compared to warfarin and heparin.
Bleeding events associated with the new medications included:
- Hip surgery – 1.43-fold increased rate of major bleeding
- Acute coronary syndrome – 3.27-fold increased rate of major bleeding
- Medically ill thromboprophylaxis – 2.79-fold increased rate of major bleeding
Signs and symptoms of Xarelto bleeding may vary depending on the location of the bleeding and what body functions are affected. In general, however, symptoms of internal bleeding may include:
- Unusual bleeding
- Discolored urine (blood in the urine)
- Red or black-colored stool
- Coughing up blood
- Vomiting blood that looks like coffee grounds
- Frequent nose bleed or gum bleeding
- Weakness and swelling in the extremities
Although uncontrollable bleeding episodes are the most common serious side effect associated with Xarelto, there has been growing concern about blood clots in patients who take Xarelto as a prophylaxis. These patients tended to be younger [median age 66] who took Xarelto after hip or knee replacement surgery. According to a QuarterWatch Report issued by the Institute for Safe Medication Practices (ISMP), of the 356 adverse events linked to Xarelto during the first quarter of 2012, there were at least 158 cases of blood clots or thromboembolic events reported to the FDA.
Blood Clot Symptoms
- Exhaustion or unexplained fatigue
- Redness, inflammation or varicose veins
- Shortness of breath
- Chest pain or pain with deep breathing
- Fever or sweats
- Dizziness or fainting
- Increased heart rate
- Unexplained cough
- Asymptomatic (no symptoms)
- Bloody mucus with worsening cough
Blood Clot Treatment Strategies
A study published in the Journal of the American medical Association (JAMA) in September 2014 found that most treatment options for blood clots in veins (venous thromboembolism) were similarly effective, yet major bleeding events occurred more often with blood-thinning medications like Xarelto. Researchers performed 45 randomized trials on nearly 45,000 test subjects, and found that 0.49% of patients treated with Xarelto had a major bleeding event during the first 3 months of treatment, compared to just 0.29% with Eliquis (generic: apixaban). The study’s authors concluded that, except for a UFH-vitamin K antagonist combination, all other treatment strategies had similar bleeding risks.
Although Xarelto is used to prevent ischemic strokes (stroke caused by blood clots), the medication may actually increase the risk of hemorrhagic stroke (strokes caused by bleeding in the brain). A hemorrhagic stroke, or cerebral hemorrhage, occurs when there is bleeding in the brain that permanently damages brain tissue.
Signs and symptoms of a hemorrhagic stroke may include:
- Severe headache that starts suddenly
- Nausea / vomiting
- Inability to look at bright light
- Stiff neck
‘ROCKET’ Safety Study
The largest clinical trial performed on Xarelto was called “ROCKET” (Rivaroxaban Once daily oral direct Factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial). Researchers examined data on more than 14,000 patients and compared Xarelto to warfarin. The results indicated that Xarelto was no more effective than warfarin, and that the potential health risks associated with the medications were similar. The most commonly reported side effect was internal bleeding, with rates similar to that of warfarin. However, Xarelto caused fewer brain bleeds and more bleeding events in the stomach and intestines.
There are currently over 4,500 Xarelto lawsuits consolidated in a federal multidistrict litigation (MDL-2529) before Judge Eldon E. Fallon in the U.S. District Court Eastern District of Louisiana. Discovery is underway and defendants and plaintiffs are exchanging information. Many additional complaints have been filed in state courts across the U.S.
Are Cases Being Settled?
With the Xarelto MDL currently underway, Bayer and J&J have yet to offer any significant settlements. Some experts have said that settlement talks may begin by the end of 2016, and if parties do not agree on terms the litigation trials will proceed as scheduled.
Is There a Class Action?
No class action lawsuit has yet been filed in the Xarelto litigation. In the federal MDL in Louisiana, each case is treated individually. Each plaintiff retains their own lawyer and can accept or reject settlement offers. Class actions typically involve just one plaintiff who represents an entire class. People can opt to join the class and whatever settlement is negotiated is split across the entire class and its members do not have a say in the outcome. In most cases, these are smaller awards and do not
involve severe injuries.
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.
Two Cases Picked for Xarelto Bellwether Trials
August 17, 2016 – Judge Eldon E. Fallon has selected 2 lawsuits to serve as the first test trials of more than 7,200 federal cases alleging severe bleeding complications from Xarelto, according to Reuters. The first trial, scheduled to begin in February, involves claims Xarelto caused a Louisiana man to develop gastrointestinal bleeding.
July 1, 2011 – First approved by the FDA
Xarelto first approved by the U.S. Food & Drug Administration (FDA).
September 8, 2011 – Clinical trial findings
‘Rocket” clinical trial finds Xarelto no more effective than warfarin, and more bleeding events in the stomach and intestines with Xarelto.
November 4, 2011 – Approval expanded
Xarelto’s approval expanded to include the prevention of stroke in patients with abnormal heart rhythms (atrial fibrillation or A-fib).
January 9, 2012 – NICE refusal
The U.K.’s National Institute for Health and Clinical Excellence (NICE) refuses to recommend or approve Xarelto for use in state health services until Bayer can provide more safety data on the drug.
October 3, 2012 – ISMP QuarterWatch Report findings
ISMP QuarterWatch Report finds at least 356 adverse events associated with Xarelto during the 1st quarter of 2012, including 158 cases of blood clots or thromboembolic events.
November 21, 2013 – Medscape study findings
Medscape study finds a 3-fold increased risk of bleeding in acutely ill patients treated with Xarelto, as well as a 4-fold increased risk of major bleeding in patients with acute coronary syndrome (ACS).
September 16, 2014 – JAMA study findings
JAMA study finds that 0.49% of Xarelto users had a major bleeding event during the first 3 months of treatment, compared to just 0.29% with Eliquis.
December 17, 2014 – Xarelto federal multidistrict litigation
Xarelto federal multidistrict litigation (MDL-2529) formed in the U.S. District Court, Eastern District of Louisiana.
- “Health Guide – Hemorrhagic Stroke”. The New York Times. September 16, 2008.
- “Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation”. The New England Journal of Medicine (NEJM). September 8, 2011.
- “FDA approves Xarelto to prevent stroke in people with common type of abnormal heart rhythm”. U.S. Food & Drug Administration (FDA). November 4, 2011.
- “UPDATE 1-UK cost agency wants more data on Bayer anti-clot drug”. Reuters. January 9, 2012.
- “QuarterWatch Report: Why Reports of Serious Adverse Events Continue to Grow”. Institute for Safe Medication Practices (ISMP). October 3, 2012.
- “Bleeding With New Oral Anticoagulants Depends on Clinical Setting”. Medscape. November 21, 2013.
- “Study Compares Effectiveness of Treatments for Blood Clots”. The Journal of the American Medical Association (JAMA). September 16, 2014.
- “MDL – 2592 Xarelto Products Liability Litigation”. United States District Court, Eastern District of Louisiana. December 17, 2014.
- “Atrial fibrillation, oral anticoagulant drugs, and their reversal agents”. U.S. Food & Drug Administration (FDA). October 16, 2015.