What Is Xarelto® and Why Is It Dangerous?
Posted on Monday, April 16th, 2018 at 4:46 pm
Blood’s ability to coagulate is an essential component of healing. Blood clots close off cuts and even internal bleeding to prevent excessive and dangerous blood loss. However, there are certain conditions in which unwanted blood clotting may pose a significant risk. If a patient has a condition where blood clots could potentially lead to a catastrophic health issue, doctors will often prescribe a blood thinner. Xarelto is one of those blood thinners.
What Conditions May Cause a Doctor to Prescribe Blood Thinners?
Deep vein thrombosis (DVT) is one such issue that may necessitate the use of blood thinners. DVT occurs when a blood clot forms in a vein, most often deep in the legs. If that clot breaks free or parts of the clot break off, they can be carried to the lungs and potentially block blood flow. This results in a pulmonary embolism, characterized by symptoms including chest pain and sudden shortness of breath.1
People who have atrial fibrillation (AFib) are also commonly prescribed blood thinners. AFib, an abnormality in heart rhythm, is linked with heart failure and an increased risk of stroke. Patients with AFib have a higher likelihood of developing blood clots, which can break loose and travel to the brain. It’s this risk that often necessitates the use of blood thinners.
Blood thinners are also sometimes prescribed after major surgeries, especially hip and knee replacements. Blood flow has a tendency to become sluggish in some patients after these invasive surgeries, increasing the risk for blood clotting in veins. Some patients are prescribed blood thinners after invasive surgeries to prevent this clotting from occurring.
Lawsuits Relating to Xarelto
There have been several high-profile Xarelto-related lawsuits brought against Johnson & Johnson (J&J) and Bayer. A victory for a plaintiff on December 5, 2017 resulted in a $27.8 million jury verdict against the two pharmaceutical companies. The plaintiff claimed the manufacturers had not done enough to inform and educate patients and their health care providers on the potential risks of Xarelto if a bleed were to occur.2
On January 9, 2018 – barely a month later – the judge overturned that verdict. The plaintiff’s physician testified that even if the warning on Xarelto’s label had been more robust, she still would have prescribed it.3
So far, the pharmaceutical companies have won all of the major cases brought against them relating to Xarelto warnings, but there are currently more than 20,000 similar claims pending.
Updated Warning Labels
J&J and Bayer’s problems surrounding Xarelto aren’t going away anytime soon. They’re also not new. The U.S. Food and Drug Administration (FDA) has repeatedly voiced concerns over Xarelto’s warning label. In August 2013, the companies were told they needed to add a warning of increased spinal bleed risk. In January 2014, they had to clearly disclose the fact that there was no antidote should a bleed occur and that patients who had a prosthetic heart valve shouldn’t take Xarelto.4
This is another key complaint of patients. Many blood thinners have a corresponding antidote that can be taken should a bleed occur to once again allow clotting. Xarelto has no such antidote.5
In March 2014, December 2014 and May 2016, J&J and Bayer were again asked by the FDA to add warnings for medical professionals regarding spinal bleeds, adverse reactions for patients with thrombocytopenia and hepatitis and increased risk for bleeding in patients taking SSRI and SNRI antidepressants.
The FDA has repeatedly and publicly required Xarelto’s manufacturers to improve risk disclosures to patients and health care providers. In all recent lawsuits, J&J and Bayer argued that their warnings are adequate, a claim that seems to conflict with past history of regulatory actions intended to correct what the FDA viewed as inadequate warnings.
The Importance of Xarelto in Modern Medicine
Most physicians are likely well aware of Xarelto risks considering the high-profile cases and significant media coverage of the regulatory actions taken against J&J and Bayer. Despite the highly publicized issues, Xarelto is still being prescribed frequently. In 2016, the companies earned more than $2 billion in sales revenue from Xarelto alone. By the end of their third quarter in 2017, the companies had racked up $1.8 billion of revenue off Xarelto sales for the year.6
The bottom line is, from J&J and Bayer’s perspective, Xarelto is a huge money maker. With that kind of revenue stream, it’s no wonder these pharmaceutical companies are refusing to give any ground. Even if the $27.8 million verdict had not been overturned, it still would have equated to a drop in the bucket compared with the drug’s revenue generation and its potential as a future revenue stream.
Has Your Family Been Affected by Xarelto?
If you or a loved one has experienced bleeding or other issues after taking Xarelto for AFib, hip or knee replacement surgery or DVT, you owe yourself a call to Farris, Riley & Pitt. Our dangerous drug attorneys in Alabama will examine your case to provide honest feedback regarding your potential to collect compensation. We are committed to holding drug companies accountable for dangerous drugs that lack adequate warnings, regardless of the resources at their disposal.
Schedule a free case evaluation by calling (205) 324-1212.