For years, patients who were on blood thinners had to return for lab work on a regular basis – sometimes as often as once a week. Doctors required this of the patient because any number of things could affect the required dosage – diet, exercise, illness, and even other medications. So when Xarelto became available, both the medical community and the public were thrilled.
However, doctors and their patients soon found that the negative side effects of the drug may outweigh the benefits.
Xarelto: A History Of The Drug
Xarelto was developed by Bayer AG and Janssen Pharmaceuticals. This new blood thinner was heralded as a revolutionary new blood thinner, one that would change the way patients with clotting disorders were treated. The U.S. Food and Drug Administration granted approval for the drug in 2011.
Patients were most excited about the fact that Xarelto is the same dosage for everyone taking the drug, regardless of their age, diet, or health conditions. This means that fewer rechecks are required by the physician.
Thousands of prescriptions were written for the drug for men and women to prevent clots or deep vein thrombosis after surgery, treat patients with clotting disorders, or to treat atrial fibrillation. Unfortunately, it didn’t take long for the side effects of the drug to send those same patients back to the hospital.
These side effects have included uncontrollable bleeding, pulmonary embolism, gastrointestinal bleeding, stroke, brain hemorrhage, rectal bleeding, liver dysfunction, and spinal bleeding.
Spinal Bleeding Side Effects
Spinal bleedings can occur for many reasons, but most often the spine experiences some sort of trauma, or the patient requires an epidural or other surgical procedure.
When bleeding begins in the spine and the patient is on Xarelto, the blood will continue to pool around the spinal cord. When this pooling occurs, pressure is placed on the spinal cord and sensory functions to the brain can be shut off. This may result in partial or total paralysis, that may or may not be permanent.
This risk is so serious that the FDA placed a black box warning on the label telling doctors that anyone who planned on undergoing a spinal procedure should wait until the drug is completely out of their system. A black box warning is the most stringent warning that the FDA can give – and Xarelto has two.
What makes the drug even more dangerous, is that there is no known reversal agent. This means that once bleeding starts, doctors must rely on blood transfusions to regain control, which in many cases is not enough. Older blood thinners do have a reversal agent – Vitamin K.
The Lawsuits Regarding Xarelto
Since January of 2014, hundred of complaints have been filed, each one alleging that the drug caused a life threatening side effect which resulted in suffering in a plaintiff. Sadly, many of these lawsuits have been filed by the family members of those whose uncontrollable bleeding resulted in their death.
The plaintiffs are seeking compensation for the money they have had to spend on medical expenses, lost wages from time off of work, pain and suffering, and funeral and burial expenses. In December of 2014, Xarelto lawsuits were consolidated to a federal court in the Eastern District for Louisiana. Plaintiffs were excited when the MDL announcement was made, because it means that the litigation process will be streamlined, saving everyone involved time and money.