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The Xarelto lawsuit claimed that Xarelto could cause irreversible internal bleeding, and that a substitute medication was just as effective at reducing blood clots but without the life-threatening danger of excessive blood loss.
The most serious potential injury caused by Xarelto is internal bleeding. Currently, there is no known potential cure to reverse the type of blood loss caused by Xarelto, other than possibly emergency dialysis. Individuals with severe pulmonary arterial hypertension are at greater risk for experiencing a Xarelto related bleed.
The Main Concern
While a warfarin overdose can be treated with Vitamin K and other substances, doctors can only wait for Xarelto to be flushed out from the patient’s body when extensive blood loss begins. Not even dialysis may be sufficient, and even a simple gastrointestinal bleed can become a fatal hemorrhage.
Other potential injuries caused by Xarelto include infection associated with hip or knee replacement surgery; decreased hemoglobin (a substance that carries oxygen in red blood cells); hematoma (a mass in the blood); peripheral edema (swelling of the lower limbs); and dyspnea (difficulty breathing).
If you are currently taking Xarelto, it is important to do your best to avoid activities that could result in you getting cut or bruised. If you do sustain these types of injuries (and especially if you experience swelling, bruising, bleeding, vision changes, confusion, weakness, dizziness or a migraine headache), immediately inform your healthcare provider.
Make sure to tell all doctors of your use of Xarelto, especially before undergoing any medical/dental procedures and surgeries, or if you have an artificial heart valve, uncontrolled high blood pressure, abnormal kidney function, ulcers, take medication associated with bleeding (e.g. aspirin), or abuse alcohol.
If you are, or become, pregnant make sure your obstetrician-gynecologist is clearly aware of this information, and especially before receiving an epidural.
Do not stop taking Xarelto, or reduce your dosage, without first consulting with your treating physician.
As of March 2019, there had not been a recall of Xarelto related to internal bleeding. However, the FDA has issued several warnings regarding the dangers of the drug.
In June 2013, the FDA sent a warning letter to Johnson & Johnson after it was determined that the company’s subsidiary Janssen Pharmaceuticals, and its development partner Bayer AG, failed to properly warn patients and doctors in marketing material of the serious side effects linked to Xarelto (rivaroxaban). The letter stated that Johnson & Johnson’s print ad for Xarelto was “false or misleading because it minimizes the risks associated with Xarelto and makes a misleading claim.”
In August 2013, the FDA mandated that Xarelto packaging contain a black box warning stating that patients who stopped taking Xarelto prematurely could have an elevated risk for deep vein thrombosis, embolism, and spinal hematoma.
In 2014, the manufacturer of Xarelto was required to provide additional information on interactions with anesthesia and various other medications, including CYP3A4 inhibitors as well as the herbal supplement St. John’s Wort. Warnings regarding the effects on renal function, and the lack of an antidote were also mandated later that year.
Xarelto is an anticoagulant (blood thinner) first approved by the FDA in 2011. Since that time, it has been widely prescribed to prevent blood clots in patients suffering from atrial fibrillation (irregular heartbeat); deep vein thrombosis (blood clots deep within the body); pulmonary embolism (blood clots in the lungs); stroke; and patients who have recently undergone a knee or hip replacement surgery.
Xarelto generally is prescribed as an alternative to warfarin (Coumadin), a blood thinner that began to be used in 1954. The primary benefit of Xarelto over warfarin is the manufacturer claims the drug requires little patient monitoring, blood tests, and the dosage level is standard for virtually all users. Whether this statement is true is being addressed in pending litigation.
Xarelto is a Factor Xa (10-A) Inhibitor, which is a biochemical substance produced in the liver that plays an important role in blood clotting. It operates by disabling the production of Factor Xa, which is dependent upon Vitamin K.
Xarelto is specifically prescribed for patients who:
Johnson & Johnson and Bayer have already prevailed in several lawsuits claiming their anticoagulant Xarelto caused severe injuries, and now a judge has ordered 1,200 more cases to be prepared for trials in courts around the country. Reported in FiercePharma- Judge Orders Trials
A Philadelphia state court jury on Tuesday ordered Bayer AG and Johnson & Johnson to pay $27.8 million to an Indiana couple over the drugmakers’ failure to warn of internal bleeding risks from their blood thinner Xarelto. Reported in Reuters – Philadelphia Xarelto Jury Verdict
A Pennsylvania state court judge on Tuesday overturned a $27.8 million jury award to an Indiana couple who accused Bayer AG and Johnson & Johnson of failing to warn of internal bleeding risks of their drug Xarelto, the companies said. The next trial is May 30. Reported in Reuters – Reversal of Jury Verdict
It is a startling accusation, buried in a footnote in a legal briefing filed recently in federal court: Did two major pharmaceutical companies, in an effort to protect their blockbuster drug, mislead editors at one of the world’s most prestigious medical journals? Reported in New York Times – Xarelto Faulty Data
As the number of lawsuits against the blood thinner Xarelto continues to climb, so do reports of injuries and deaths caused by the controversial anticoagulant, according to a recent study by the Institute for Safe Medication Practices. According to ISMP, the U.S. Food and Drug Administration received 15,043 reports of serious injury or death linked to Xarelto last year — a 41 percent increase over the previous year. Reported in Market Insider – Xarelto Adverse Events
A federal jury has cleared Bayer AG and Johnson & Johnson of liability in the first trial to flow out of thousands of lawsuits blaming injuries on the blood thinner Xarelto, the drugmakers said on Wednesday. . . . The lawsuit is one of an estimated 18,000 lawsuits in federal and state courts related to Xarelto. The verdict came in the first of four test trials, or bellwethers, scheduled in the federal litigation. The next trial is May 30. Reported in Reuters – Xarelto Trial
The ROCKET-AF trial compared Xarelto with warfarin in more than 14 000 people. The trial used the INRatio device, made by Alere, to determine whether, and by how much, patients’ doses of warfarin should be adjusted to keep the drug in the right therapeutic range. Too much warfarin and patients are at an increased risk of bleeding; too little and they are at risk of clots. Reported in British Medical Journal – Xarelto Data on Trial
Xarelto can cause bleeding, which can be serious, and might lead to death. This is because Xarelto is a blood thinner medicine that reduces blood clotting. Reported in FDA – Xarelto Guide
In this trial comparing a once-daily, fixed dose of rivaroxaban with adjusted-dose warfarin in patients with nonvalvular atrial fibrillation who were at moderate-to-high risk for stroke, rivaroxaban was noninferior to warfarin in the prevention of subsequent stroke or systemic embolism. There were no significant differences in rates of major and clinically relevant nonmajor bleeding between the two study groups, although intracranial and fatal bleeding occurred less frequently in the rivaroxaban group. Reported in New England Journal of Medicine – Xarelto vs Warfarin
Xarelto increases the risk of bleeding and can cause serious or fatal hemorrhaging. In deciding whether to prescribe Xarelto, the risk of thrombotic events should be weighed against the risk of bleeding. A specific antidote is not available. Reported in FDA – Xarelto Information
We cannot rule out as much as a 50% increase in the risk of gastrointestinal bleeding with dabigatran compared with warfarin or a more than twofold higher risk of bleeding with rivaroxaban (Xarelto) compared with warfarin. Reported in British Medical Journal – Xarelto vs Warfarin
In the first quarter of 2012, QuarterWatch identified 356 reports of serious, disabling, or fatal injury in which rivaroxaban [Xarelto] was the primary suspect drug. The total more than doubled from the previous quarter of 128 cases. Reported in Institute for Safe Medication Practices – Xarelto Safety
Since 2012 QuarterWatch has reported prominent signals for the bleeding risks of three anticoagulant drugs, dabigatran (PRADAXA), rivaroxaban (XARELTO), and warfarin (COUMADIN). The concerns arose in a setting of a race to market replacements for warfarin, a generic drug first approved in 1956. Both dabigatran and rivaroxaban were marketed as providing the same or slightly better results than warfarin in preventing strokes and other blood clot-related events, but were easier to use because weekly or monthly blood level tests were not required or available. Reported in Institute for Safe Medication Practices – Xarelto Hypersensitivity
Because of the concern about the Alere INRatio device, the FDA has completed a variety of analyses to assess the impact that this faulty monitoring device had on the ROCKET-AF study results. The Agency has determined that effects on strokes or bleeding, including bleeding in the head, were minimal. The FDA concludes that Xarelto is a safe and effective alternative to warfarin in patients with atrial fibrillation. Reported in FDA – Xarelto Analyses
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