Xarelto is a blood-thinning medication that has been linked to an increased risk of severe, sometimes fatal bleeding. When Xarelto was introduced in 2011, it had no antidote and some doctors struggled to stop bleeding in patients who had injuries or needed emergency surgery.
1st Xarelto Trial Set for April 24, 2017
The first “bellwether” trial out of 17,000 Xarelto lawsuits involving uncontrollable bleeding is set for April 24, followed by another trial on May 30, unless lawyers agree on a settlement this month. Meanwhile, lawyers are wasting no time in ripping apart clinical trials that drug-makers used to justify once-daily dosing. All of the lawsuits accuse drug-makers of downplaying the risk of uncontrollable bleeding.
What is Xarelto?
Xarelto (rivaroxaban) is a blood-thinning drug that was developed by Bayer HealthCare. It was approved by the FDA in July 2011 and is now sold by Janssen Pharmaceuticals (Johnson & Johnson). Xarelto is used to reduce the risk of stroke in patients who are at risk of blood clots due to atrial fibrillation (abnormal heart rhythm) or hip/knee replacement surgery.
What’s the problem?
When Xarelto hit the market in 2011, it had no reversal agent. This is a problem because doctors might be unable to reverse its effects in an emergency, which could increase the risk of uncontrollable bleeding. In comparison, warfarin can easily be reversed with a dose of Vitamin K. Xarelto has also been linked to higher rates of bleeding than Pradaxa.
Possible Antidote Discovered
It was not until January 2015 that Portola Pharmaceuticals announced a possible antidote for Xarelto had been discovered. A late-stage clinical trial of the intravenous medication, AndexXa (andexanet alfa), met its primary endpoint of “immediately and significantly” reversing Xarelto. However, in August 2016, the FDA delayed approving the antidote.
17,000 Xarelto Lawsuits Filed
As of April 2017, around 17,000 Xarelto lawsuits were pending nationwide. That includes more than 15,600 lawsuits in Multi-District Litigation (MDL No. 2592) under Judge Eldon E. Fallon in the Eastern District of Louisiana. Another 1,400 cases have been centralized in a mass-tort in the Philadelphia County Court of Common Pleas.
1st Trials Set for April 2017
The first “bellwether” trials were scheduled for February 2017 in Louisiana, but they were delayed until April 24, 2017. The first trial will involve a man who experienced severe gastrointestinal bleeding. The second trial will involve a woman who died of severe bleeding in her brain after taking Xarelto. Click here to read more.
What is the Risk of Bleeding?
ROCKET-AF was a pivotal clinical trial that compared Xarelto to wafarin. Researchers concluded that Xarelto and warfarin were equally effective and had comparable risks:
- Major bleeding: Xarelto (5.6%) – Warfarin (5.4%)
- Gastrointestinal (GI) bleeding: Xarelto (3.1%) – Warfarin (2%)
- Bleeding in a critical organ: Xarelto (1.3%) – Warfarin (1.9%)
- Fatal bleeding: Xarelto (0.4%) – Warfarin (0.8%)
- Bleeding resulting in transfusion: Xarelto (2.6%) – Warfarin (2.1%)
Xarleto Doubles Risk of Intestinal Bleeding
The ROCKET-AF trial concluded that Xarelto caused less bleeding in the brain and more bleeding in the stomach and intestines. In April 2015, the British Medical Journal published a study that found Xarelto could double the risk of gastrointestinal bleeding compared to warfarin.
Problems With ROCKET-AF
The safety and effectiveness of Xarelto has been questioned, after an editorial in the New England Journal of Medicine found that the use of multiple statistical analyses “muddied the waters” when it came to determining the drug’s safety.
One of the three FDA reviewers who examined the data found that the drug-makers failed to administer warfarin in an optimal way, which may have skewed the data. A defective INR-testing device used to calibrate warfarin dosage may have skewed results of the ROCKET-AF clinical trial in favor of Xarelto.
Signs & Symptoms of Bleeding
The warning signs and symptoms of bleeding vary widely depending on the location and amount of blood being lost. If more than 20% of blood is lost, the patient can go into hypovolemic shock. This causes organs to shut down because they do not receive blood they need to survive.
Warnings signs and symptoms of bleeding:
- Bruising easily or bruises that do not heal
- Urine is red or tea-colored
- Stools are red, black, or tarry
- Vomit is bloody or looks like coffee grounds
- Nosebleeds that do not stop
- Trouble breathing or swallowing
- Coughing up blood
- Menstrual periods are very heavy
- Cuts and wounds that do not stop bleeding
- Severe headache or dizziness
- Shock (paleness, weakness, low blood pressure, etc.)
- Unexplained pain, swelling, or discomfort
Thousands of lawsuits have been filed by people who were injured by Xarelto, but not as part of a class action. Instead, they are individual lawsuits that were centralized in federal court against the objections of Bayer and Janssen.
In 2015, the size of the litigation skyrocketed from 80 cases in January to over 2,200 by December. Another 850 lawsuits have also been centralized in a mass-tort in Pennsylvania. The judge overseeing the federal litigation has appointed 12 attorneys to leadership roles and set the first four trial dates for February 2017.
The first lawsuits involved plaintiffs who developed severe bleeding after taking Xarelto for just a few months, including several who developed bleeding in the brain or subdural hemorrhage. Many of these cases involve patients who bled to death because doctors were unable to deactivate Xarelto.
In October 2014, the FDA issued a Class II recall for about 13,500 bottles of Xarelto after receiving one customer complaint about microbial contamination in a sales sample.