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 to treat 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 use and indication
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 into the pulmonary circulation system, causing a PE. Pulmonary embolism (PE) is a blockage (blood clot) in the pulmonary artery, which is the blood vessel responsible for carrying blood to the lungs from the heart. PE is a potentially lethal reaction as it hinders the delivery of blood to your lungs.
Venous thromboembolism (VTE) is also very detrimental to our health and is a major worldwide cause of morbidity and mortality. VTE is the culprit behind a death toll of approximately 300,000 per year in the USA and 540,000 in the EU.
6% of all patients affected by DVT die, as up to to 12% of all patients affected by PE. Many researches have showed that after 2 years after the incidence of DVT, 22-40 % 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 labelling 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 warfarin for preventing stroke and systemic embolism and could be an alternative to warfarin.
Xarelto comes in four doses; 20 mg / 10 mg / 10 mg film-coated tablets and 2.5 mg film-coated tablets. The active ingredient of Xarelto 2.5 mg is 2.5 mg rivaroxaban with excipients such as titanium dioxide (E171), iron oxide yellow (E172), 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 with the evening meal. 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
Dangerous side effects of Xarelto is uncontrolled internal bleeding.
When haemorrages develop near major organs, such as the lungs, kidneys, or brain, or even any minor trauma happens – the functionality of these organs is damaged and the blood flow becomes uncontrollable. Since Xarelto prevents clotting, the bleeding will continue until the body flushed out drug. Unlike warfarin, there is no antidote for Xarelto, so doctors find it near impossible to immediately and effectively stop the haemorraging, 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 the subsequent 90 days after a patient suffered from acute coronary syndrome (ACS). 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 standards of medicine screening and testing to ensure its efficiency.
- 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) tablets” Reference 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.