XARELTO: uses, doses and adverse bleeding effects

Xarelto (rivaroxaban) is a blood-thinning medicine used systemically to interrupt the formation of blood clots in the legs and lungs in subjects who underwent recent knee or hip replacement surgeries and for the therapy of pulmonary embolism (PE), deep vein thrombosis (DVT) and atrial fibrillation (Afib). Anticoagulant drugs are used to reduce the ability of blood to clot. Even if the process of clotting is n fundamental and essential part of the wound healing mechanism, excess clotting in the blood vessels can increase the risk of heart attacks and strokes. Anticoagulant are also called blood-thinning medicines, however, this is technically unacceptable. Warfarin is the most widely used blood thinner in the history of medicine.

Xarelto uses and indications

Xarelto functions to treat venous thromboembolism (VTE) which is a disease that includes deep vein thrombosis (DVT) and pulmonary embolism (PE). DVT is caused by a blood clot that clogs a vein usually in a leg or in the arms. If a blood clot fragment dissociates, it migrates downstream from the heart to the lungs, causing a PE. Pulmonary embolism (PE) is a blockage (blood clot) in the pulmonary artery, a large blood vessel responsible that links the heart to the lungs. PE is a potentially lethal reaction as it hinders the delivery of blood to your lungs.

VTE is also very detrimental to our health and is one of the principal global causes of morbidity and mortality. VTE is the culprit behind about 300,000 patient’s deaths per year in the USA and 540,000 in the EU.

6 percent of all patients affected by DVT die, as up to to 12 percent of all patients affected by PE. Many types of research have shown that after 2 years after the incidence of DVT, 22-40 percent of patients suffer from post-thrombotic syndrome – a condition that has a deleterious impact on the quality of our life. Rivaroxaban is also used to treat arterial fibrillation (AF), which is defined as an abnormal heart rhythm characterized by tachycardia.

Xarelto has been recently approved by the FDA prevent the risk of stroke in patients with Afib but with labeling a black boxed warning. The cause of this warning is sourced to that, a stop in taking Xarelto without medical supervision can increase the risk of stroke. Several studies indicated that rivaroxaban was superior to warfarin for preventing stroke and systemic embolism and could be an alternative to warfarin.

Xarelto is available in four dosages; 20 mg / 10 mg / 10 mg film-coated tablets and 2.5 mg film-coated tablets. Rivaroxaban 2.5 mg is the active ingredient of Xarelto. The excipients used include iron oxide yellow (E172), titanium dioxide (E171), and microcrystalline cellulose. It is mainly used to prevent blood clots in adult subjects who suffered from an acute coronary syndrome (ACS). While the active ingredients in 10 mg / 15 mg / 20 mg film-coated tablets are 10 mg / 15 mg / 20 mg rivaroxaban and excipients such as microcrystalline cellulose, titanium dioxide (E171), iron oxide red (E172) and others. Xarelto 10 mg is used to prevent VTE in adult subjects who underwent hip or knee replacement operations and 15 mg / 20 mg are used for preventing systemic embolism and stroke in adult subjects affected by nonvalvular Afib. Xarelto is taken orally as properly prescribed by your doctor. In the case of taking Xarelto for the prevention of excessive coagulation joint replacement surgery, the dose prescribed is usually taken once a day. And if you are taking it to prevent strokes and blood clots, the dose is usually taken once a day during meals, especially in the evening. The 20 mg and 15 mg doses should be taken with food, while the 10 mg one may be taken even without food .

In the case of an overdose, there’s a high risk of uncontrolled bleeding. You must seek immediate medical help or call the Poison Help line at 1-800-222-1222.

Xarelto is the most prescribed blood thinner drug with over 11 million yearly prescriptions just in the United States. Experts expect this number to increase even further in the upcoming years. Rivaroxaban is manufactured and marketed by Bayer AG and Janssen Pharmaceuticals (a unit of Johnson & Johnson). In 2013, this medication sales earned $1.3 billion of net profit. Xarelto’s dark side, however, is very dangerous. The drug is associated with a ton of so life-threatening adverse reactions that could compromise its efficacy and safety. Some of the worst side effects are:

  • Paralysis, Headache, Dizziness, and Numbness
  • Back pain and Bleeding gums.
  • Brain Hemorrhage and Abdominal Bleeding
  • Abnormal Liver Function and Reduced Platelet Levels

 

The most dangerous side effect of Xarelto are uncontrollable haemorrhages

xarelto lawsuit

When haemorrhages develop close to the organs, such as the lungs, kidneys, or brain, or even any minor trauma occurs – these organs’ functionality is damaged and the blood flow becomes uncontrollable. Since Xarelto stops clotting, the bleeding will continue until the drug is flushed out of the body. Unlike warfarin, no antidote for Xarelto is available, so doctors find it near impossible to immediately and effectively stop the haemorrhaging, leading to many deaths. In response to the fatality of Xarelto irreversible bleeds, a surge in medical/community concerns about the efficacy of Xarelto was marked. Back in 2014, the FDA refused to grant approvation to widening the indications of this drug, and voted three times in a row against the approving the blood thinner to be used in after acute coronary syndrome (ACS) occurs in a patient. In June 2014, Virginia Stuntebeck file the first litigation against Bayer in a Philadelphia Court, claiming that rivaroxaban was responsible for the internal bleeding she suffered. Every year, science makes new leaps in the field of medicine, significantly improving our health with new treatment alternatives. At last, we should praise the strenuous efforts exerted by FDA, our guardian angel and final barrier, to maintain the highest quality of medicine screening and testing to grant its efficiency.

 

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References:

  • AG, Bayer Pharma. “Xarelto®(rivaroxaban) summary of product characteristics. 2013.” (Accessed August 2015).
  • U.S. Food and Drug Administration (FDA). “MEDICATION GUIDE XARELTO® (zah-REL-toe) (rivaroxaban) tabletsReference ID: 3688029. (Accessed July 2016)
  • Xi, Guohua, et al. “Role of blood clot formation on early edema development after experimental intracerebral hemorrhage.” Stroke 29.12 (1998): 2580-2586.
  • US Food and Drugs Administration (FDA) Xarelto (Rivaroxaban) Tablets. www.fda.gov. (Retrieved September 2015)
  • WebMD. XARELTO Side Effects. http://www.webmd.com/ (Retrieved October 2015)
  • Bleeding with dabigatran, rivaroxaban, apixaban. No antidote, and little clinical experience.” Prescrire Int. 2013 Jun;22(139):155-9.