How Does Xarelto Work?
Xarelto is a blood thinner that is prescribed to millions of people to prevent blood clots that cause strokes. Xarelto is an Xa inhibitor, which means that it blocks thrombin, the chemical in your blood that is used to clot blood. This in turn is supposed to breakdown clots and prevent clots and deep vein thrombosis that individuals typically experience after hip or knee replacement surgery, or those treating atrial fibrillation.
What Are The Risks of Using Xarelto?
Blood thinners all come with risks. Specifically, if your blood cannot clot or coagulate, then a fall, surgery, or other medical procedure can cause lesions or bleeds that will not clot and stop the bleed. This in turn causes severe hematoma (pools of blood) surrounding organs, where it should not be. It also results in cutting off the blood supply to vital organs which can have devastating consequences.
Is There An FDA Xarelto Recall?
To date, there has not been a recall on Xarelto. The Food and Drug Administration has issued several important safety communications regarding Xarelto and two “black box warnings”. A black box warning, also referred to as a “boxed warning”, is the most strict warning that the FDA can issue with respect to a drug. It usually means that there is “reasonable evidence” of an association of a hazard. Below is a summary of FDA notifications on Xarelto:
- December 2014 – The FDA issued an “Adverse Reaction” report on Xarelto. Specifically this adverse reaction communication related to the recognition of Xarelto causing low blood platelet counts or a condition known as thrombocytopenia. According to the Mayo Clinic, thrombocytopenia can result in internal bleeding because blood platelets are crucial to forming clots to stop bleeding. This update by the FDA also changed an adverse reaction description from “cytolytic hepatitis” to “hepatitis”, which included hepatocellular injury, which is a major liver injury.
- March 2014 – The strictest FDA warning was issued where they had reasonable evidence that Xarelto was causing serious injury in patients who were undergoing an epidural (spinal anesthesia/analgesia) or spinal puncture. The warning specifically stated that if someone needed such a procedure, it is recommended that they wait until Xarelto has been flushed from the system.
- January 2014 – The FDA issued a “warning/precaution” with respect to Xarelto/Rivaroxaban stating that they were aware of a risk of bleeding, and recommended blood transfusions or blood replacement if there were symptoms of blood loss in a patient who took Xarelto. This warning also referenced the fact that there is no antidote or reversal agent for Xarelto. Typically doctors can administer vitamin K or protamine sulfate to counteract the anti-coagulation properties of a blood thinner, however, due to the way in which Xarelto works, by blocking Thrombin, this will not work.
- August 2013 – Another black box warning was issued for Xarelto. This warning stated that patients who prematurely discontinued Xarelto were at a higher risk of blood clots, deep vein thrombosis, and epidural/spinal hematoma.
What Other Drugs Have Adverse Effects If Taken With Xarelto?
In early 2014, the FDA issued a warning regarding Xarelto. In this warning the FDA stated that Xarelto should not be taken where a patient was taking one of . The complete list is below:
- Itraconazole – Sporanox and Onmel
- lopinavir – Kaletra
- Ritonavir – Norvir
- Indinavir – Crixivan
- Conivaptan – Vaprisol
- Carbamazepine – Tegretol, Tegretol-XR, Equetro, Carbatrol, Epitol, and Teril
- Phenytoin – Dilantin
- Rifampin – Rifater, Rifamate, Rimactane, and Rifadin
- St. John’s wort – Hypericum Perforatum
In addition the FDA warned that Xarelto has not been tested in patients who have a prosthetic heart valve, and warned that as a result, Xarelto should not be taken by such patients.
What Are The Side Effects Of Xarelto?
The most severe side effect associated with taking Xarelto is uncontrollable internal bleeding. Since the blood cannot clot, this often results in urgent hospitalization or unfortunately in too many cases, death. Below is a listing of some of the most severe side effects we have seen from those bringing a Xarelto lawsuit against Bayer AG and Johnson & Johnson. For more detailed information on each condition, visit our specific condition pages:
Gastrointestinal / Abdominal Bleeding
The abdomen is comprised of several crucial body organs. An internal bleed in this area, is very severe. Such bleeds can occur in the esophagus, large intestine, colon, rectum, small intestine, and anus. Below we will deal with the lower abdomen specifically. In the upper abdomen, symptoms of a gastrointestinal (GI) bleed manifest in the form of coughing up or vomiting up blood, and vomiting blood that resembles coffee grounds. Such bleeding can cause blood pooling and shut off blood to vital organs which have lead to serious Xarelto injuries and even death.
Brain Hemorrhage / Brain Bleeding or Stroke
A brain hemorrhage occurs when there is a bleed from blood vessels which carry oxygenated blood to the brain. Typically a brain bleed will result in a stroke because the brain becomes quickly starved of oxygen and blood. This results in brain damage as cells start to die, and has the effect of a stroke. The knock on effect of this is numbness in the face, arm, or legs; slurred speech; difficulty walking or moving; excruciating headaches; impaired vision, and a lack of coordination. Unfortunately, since Xarelto stops coagulation, a clot will not form to stop the bleed and these conditions have lead to many serious injuries including paralysis and death.
A Pulmonary Embolism (PE) is a blockage of the flow of blood to the lungs because of a blood clot. The warning signs of such an event are shortness of breath, coughing up blood, and severe chest pain. The most common cause of a pulmonary embolism is deep vein thrombosis. This is a condition where a blood clot is formed in the deep veins of the arms or legs, and it travels to the lung, where the blockage occurs. In blocking the supply of blood to the lungs, the body begins to start shutting down, since oxygen is no longer being processed. One of the major risks associated with Xarelto is that it can cause blood clots if discontinued prematurely or more specifically when transitioning from Xarelto, which has no reversal agent, back to Warfarin, which has a reversal agent. A PE is very difficult to diagnose, and as a result often leads to death.
Spinal Bleeding / Epidural Hematoma
A hematoma is pooling of blood which can form clots, and cut off blood flow to vital organs. Xarelto has a specific black box warning from the FDA about adverse events regarding spinal bleeds, spinal puncture, and epidural hematoma. Patients who require these procedures can often find themselves dealing with life threatening uncontrollable internal bleeding. This bleeding can cause pooling of blood, and in particular can cause paralysis since the blood may pool around the spinal cord, shutting of sensory functions to the brain. The FDA has warned that patients who undergo or require such spinal procedures, wait until Xarelto or blood thinners have cleared their system. An epidural hematoma unfortunately can result in brain damage (because of swelling of the brain), seizures, post-concussion syndrome, and death.
Rectal / Rectum / Colon Bleeding
The lower abdomen is comprised of the rectal, large intestine, rectum, and colon. An internal bleed in the lower abdomen can have very serious consequences. Signs that are typical of a lower abdomen bleed include: bright red blood in the stool, dehydration, fever, abdominal cramps, and maroon stool. In most cases, hospitalization is required to treat the bleeding.
According to the JAMA Internal Medicine Journal, Hepatitis or liver dysfunction can be caused by Xarelto. In fact, the FDA communicated a warning about the risk of hepatitis and Xarelto in December 2014.
Xarelto Statistics: Most Common Xarelto Side Effects
A company that specializes in analyzing adverse events communicated to the FDA released a report in 2013 reporting that over 2,100 reports of adverse events concerning Xarelto, and 1,821 citing Xarelto as the primary cause of the adverse event. Below is a graph showing the top four side effects. Others included thrombosis, cerebrovascular incidents, hematoma, dyspnea, hemoglobin deficiency, and edema.
This report also noted that hospitalization was required in 891 cases and unfortunately 183 cases involved the patient dying.