As plaintiffs throughout the country anxiously await the outcome of the third Xarelto bellwether trial, researchers continue to review data to determine if the blood thinner is really as safe as Johnson & Johnson and Bayer Inc claim it to be. Just recently, the Institute for Safe Medicine Practices (ISMP), released a report which didn’t surprise the thousands of plaintiffs who have filed lawsuits against the drug’s manufacturers.
An Extreme Number Of Adverse Events
According to the ISMP, data obtained from the U.S. Food and Drug Administration (FDA) showed that in 2016 alone, the number of reports of serious injury or death caused by Xarelto reached 15,043, a 41% increase in the number of adverse events reported from the year before.
Overall, blood thinners caused more emergency room visits in 2016 than any other class of drugs but Xarelto accounted for almost 70% of those visits. Four other blood thinners account for the remaining 30%.
What Are Xarelto Adverse Events?
In this specific reports, the majority of the adverse events reported involved internal bleeding. This matches the many reports made to the manufacturer from the medical community, which indicate that patients have suffered from:
Even a small bump to the head can result in a brain bleed, which then often results in a stroke due to the absence of oxygenated blood.
If a patient on Xarelto undergoes any sort of procedure on or near the spine or if they are involved in an accident, blood can pool around the spinal column. This can cause partial or total paralysis depending on the location of the bleed.
The abdomen has numerous organs that are associated with the GI tract and if bleeding occurs in any of these, it can be life-threatening.
While it is true that doctors and patients are typically aware of the fact that when bleeding occurs on any type of blood thinner exsanguination is a risk due to the drugs anti clothing properties, the biggest concern with Xarelto is that it, unlike other blood thinners, doesn’t have an antidote.
For example, if a patient on Warfarin begins to bleed either internally or externally, doctors are able to reverse the effect that the drug has on the blood by administering Vitamin K, which then allows the blood to clot. If a patient on Xarelto begins to bleed excessively, doctors have no reversal agent to administer. Instead, they must resort to life-saving procedures such as blood transfusions.
It is the thousands of patients and their loved ones who have suffered through these adverse events that have chosen to pursue legal action against the manufacturers.
Third Xarelto Bellwether Trial Proceeds
Currently, there are more than 15,000 lawsuits filed against Johnson & Johnson and Bayer Inc, each alleging that the drug Xarelto caused them serious harm. Due to the similarities in the allegations, these cases were consolidated into MDL 2592 and assigned to the Honorable Eldon E. Fallon in the Eastern District of Louisiana.
The plaintiffs in these cases are not only hoping to obtain compensation for their medical expenses, lost wages, and physical pain and suffering, but they also hope to bring public awareness to the dangers associated with the use of Xarelto. In fact, many believe that the drug should have been recalled by the U.S. Food and Drug Administration.
What Does The FDA Have To Say About Xarelto?
The FDA has acknowledged that there are serious risks associated with taking this blood thinner. They have released several warnings which state that:
- If a patient discontinues the drug too quickly they have a higher chance of forming blood clots.
- Patients undergoing a spinal procedure should first be taken off of the drug due to the risk of spinal bleeding.
- There is no antidote for the drug.
Despite this, the drug is still available on the market and is widely advertised as a better blood thinner due to the fact that the dose given to a patient is the same regardless of their age, sex, weight, physical activity level, and diet, which reduces the need for routine bloodwork.