Xarelto, generic name Rivaroxaban, is one of the newest anti-coagulant medications to enter the market. This blood thinning medication works as a direct thrombin inhibitor. This type of anti-coagulant was aggressively marketed as a replacement for Warfarin (Coumadin), the standard blood thinning medication for the last fifty years.
Xarelto was marketed as an easier to use medication than Warfarin. Warfarin requires continual medical monitoring through blood tests to ensure that the dosage being used is correct. Xarelto does not require continual monitoring to be effective.
Xarelto was approved in 2011 for preventing deep vein thrombosis (DVT) in patients that have undergone knee or hip replacement surgery. This was the only approved use of this medication. Later that same year, the drug was approved for the treatment of arterial fibrillation to help prevent heart attacks and strokes.
Since its emergence as a blood thinning medication, Xarelto has been associated with severe side effects due to uncontrollable bleeding, unusual blood clotting, and death.
Parties Involved In The Lawsuit
Janssen Pharmaceuticals, a division of Johnson and Johnson, and Bayer Pharmaceuticals, have been named as the Defendants in the lawsuits against Xarelto. At this time, there are over 3,000 lawsuits filed against the manufactures and developers of Xarelto. Each of these cases have stated that the pharmaceutical companies released the product without providing proper information as to the dangers of using this medication. Some of the lawsuits that have been filed against these companies include wrongful death suits.
Timeline Of Xarelto Events
Xarelto is first approved for use by the public in Canada. The medication is specified to be used for the prevention of deep vein thrombosis (DVT). This medication is not available anywhere else in the worked at this time.
The Food and Drug Administration (FDA) approves Xarelto for the use of preventing deep vein thrombosis in patients who have undergone knee or hip replacement surgeries. No other uses are approved.
July 9, 2011
Only eight days after its approval, the American Health Association publishes and article in their trade journal stating that there is no antidote for the drug Xarelto. This information was not provided during its release.
The FDA approves Xarelto for the prevention of strokes and heart attacks in patients that suffer from arterial fibrillation (A Fib). Xarelto becomes the second highest prescribed blood thinning medication over the next several months due to the almost immediate complications being experienced by a similar blood thinning medication, Pradaxa.
Reuters publishes an article stating that there is growing concern among doctors that Xarelto is a dangerous medication. Many physicians are reporting serious side effects in their patient.
Only 18 months after being released to the public, the FDA is reporting that over 600 adverse events have been reported. Worldwide, over 2,000 adverse effects have been noted with over 200 reported deaths from hemorrhaging.
Findings released by different groups at the Scientific Study event hosted by the American Heart Association show that patients who are acutely ill and take Xarelto are at three times the risk for uncontrolled bleeding. Additionally, evidence is presented that patients suffering with Acute Coronary Syndrome (ACS) are at four times the risk of uncontrolled bleeding. At this time, the manufacturers of Xarelto were trying to gain approval for the medications use in treating ACS.
The Food and Drug Administration unanimously denies Janssen Pharmaceuticals the ability to add treatment of ACS to their medication guidelines.
2014 -April 14
The Journal of the American Medical Association releases a report that people who are taking Xarelto and take any type of aspirin or non-steroidal pain reliever are at double the risk of having a bleeding event. This information had not been released by the manufacturer.
2014 -April 15
The first lawsuit is filed against the manufacturers and developers of Xarelto. It is a wrongful death suit that states that the bleeding event that led to the death of their loved one was directly related to the se of Xarelto.
Johnson and Johnson releases their third quarter data which shows that Xarelto sales equaled over $1 billion in the first nine months of 2014. Company continues to aggressively market the medication despite all the adverse events.
The number of lawsuits against Xarelto has increased to 21 and the public is beginning to learn about the dangers of this medication. Johnson and Johnson files a motion with the court to prevent the Xarelto cases from being combined into a Multi District Litigation (MDL) because it would lead to more people suing their company. Judge denies request.
The University of Basel in Switzerland concludes a study that shows a direct correlation between Xarelto and liver damage.
2014 -October 15
13,500 bottles of the drug Xarelto are recalled by the manufacturer. The FDA initiated a Class I recall due to a potential microbial contaminant in the medication.
Cases continue to enter into the court system against Xarelto. The cases are condensed into a MDL in the Eastern District Federal Court of Louisiana.
Documents are revealed that Johnson and Johnson, through their subsidiary Janssen Pharmaceuticals, spent over $20 million in the last five months of 2013 marketing Xarelto. This money was used to “encourage” doctors to change their patients over to Xarelto.
XANTUS releases a study showing that 2-3 percent of all patients taking the prescription medication Xarelto suffer from internal bleeding. At the same time, Xarelto lawsuits exceed 1,200 plaintiffs.
Xarelto cases now exceed 3,000 plaintiffs. The judge overseeing the cases requests that 40 cases be seleted for Bellwether hearings. Hearings are set for January 2017.
New study published in the Journal of the American Medical Association showing a significant risk for Xarelto users and bleeding in the eyes. Hemorrhaging in the eyes can lead to blindness.
Side Effects Associated With Xarelto
Xarelto is a blood thinning medication that inhibits the production of Thrombin, the substance contained within a blood cell that allows clotting to occur. Use of this medication has been associated with the following serious side effects:
- Hemorrhaging events from simple injuries
- Spontaneous Brain Bleeding
- Gastrointestinal Bleeding
- Rectal Bleeding
- Uncontrolled Movements In The Face and Torso (Tardive Dyskinesia)
- Abnormal Liver Functions and Liver Damage
- Reduced Platelet Counts
- Random Blood Clotting Leading to Stroke
- Potential for Hemorrhaging on the Eyes
In addition to these known side effects, many doctors discourage people who have kidney problems from using Xarelto due to possible kidney damage.
People who have experienced spinal problems or are required to have an epidural should avoid using Xarelto. Xarelto use has been associated with blod clot formation in the spine after an epidural or in spines that have been injured.
Xarelto has an extensive list of drugs that can cause serious reactions if taken with Xarelto. This includes aspirin and any non-steroidal anti-inflammatory medication that can be purchased over the counter.