Xarelto is a blood thinner or anticoagulant used to protect patients from developing dangerous blood clots. It belongs to a class of drugs known as Factor Xa inhibitors. However, Xarelto (rivaroxaban) has been linked to severe bleeding complications with no known antidote. Bayer and Johnson & Johnson's subsidiary, Janssen Pharmaceuticals, are being accused of negligence in failing to warn patients about the severe risk associated with Xarelto usage.
FDA Approves Xarelto
Xarelto was first approved by the FDA in 2011 for people recovering from knee or hip replacement surgery or for patients with atrial fibrillation (AF). Later, the FDA added approval for treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
As the most commonly prescribed blood thinner in its class, Xarelto remains a very popular drug with a huge profit potential. In 2015, it earned about $2 billion for Bayer and Johnson & Johnson. In the first quarter of 2016, the drug earned $567 million.
Side Effects Associated With Xarelto
Some of the less serious side effects of Xarelto include dizziness, headache, back pain, leg weakness, and bladder or bowel dysfunction. However, the most serious side effect of Xarelto use is potentially fatal internal bleeding. Signs a patient may have uncontrolled internal bleeding due to Xarelto use include:
- Frequent nose bleeds
- Vomiting blood or a substance that looks like coffee grounds
- Coughing up blood or blood clots
- Blood in urine
- Severe uncontrolled bleeding
- Bright red or black stools with a tarry appearance
- Wounds with pain, swelling, or new drainage at the site
- Unusual bleeding in the gums
- Low blood pressure
- Vaginal bleeding or menstrual bleeding that is noticeably heavier than normal
Most blood thinner medications carry some risk of bleeding. However, Xarelto is particularly problematic because there is no known antidote or reversal method once the internal bleeding starts. Even dialysis is ineffective to flush Xarelto from a patient's system. In comparison, administering vitamin K can stop the bleeding caused as a complication of warfarin use.
In some cases, the bleeding caused by Xarelto use can lead to hypovolemic shock. This is a life- threatening condition that happens when the body loses too much blood.
How Xarelto Interacts With Other Medications
The bleeding risk associated with Xarelto appears highest for people taking larger doses of the medication or who are also taking the following:
- Any medicine that contains heparin
- NSAIDs (aspirin, ibuprofen, naproxen)
- Other drugs for blood clots
- Plavix (clopidogrel)
- SSRIs (Zoloft, Prozac) and SNRIs (Effexor)
- Warfarin (Jantoven, Coumadin)
A number of other medications can also cause adverse interactions if taken with Xarelto, but they don't increase bleeding complications.
What Xarelto Lawsuits Have Been Filed?
Presently, there are over 4,500 Xarelto lawsuits being consolidated into federal multidistrict litigation (MDL). A number of additional suits have been filed in state courts, but no settlements have been reached at this time.
The circumstances of each case vary, but plaintiffs are seeking compensation for emergency room visits, ongoing medical care, lost wages, and/or the funeral expenses of a patient who died as the result of Xarelto bleeding. Punitive damages are also being pursued, which will hold Bayer and Janssen Pharmaceuticals financially liable for releasing a dangerous drug to the unsuspecting public.
In addition to monetary compensation, many of the Xarelto plaintiffs are asking that the drug be removed from the market. Xarelto's safety labeling has been updated by the FDA several times since it was released, but the drug is still being prescribed to patients.
Although the Xarelto cases are still pending, it should be noted that a similar drug, Pradaxa, was the subject of litigation after it caused irreversible bleeding for thousands of patients. Pradaxa's manufacturer, Boehringer Ingelheim, eventually paid $650 million to settle 4,000 cases. A key argument in the Pradaxa cases was that the manufacturer should not have released a drug linked to internal bleeding with no known antidote.
We Can Help
If you or someone you love suffered serious side effects caused by Xarelto, you should obtain legal representation. Neblett, Beard & Arsenault works to protect the interests of patients who’ve been harmed by the medications they trusted to keep them healthy. Schedule a free, no-obligation case review today. You can also call us directly at 800.256.1050.