Xarelto, Bayer’s latest blood thinning medication, has brought in billion of dollars in profit and continues to be prescribed by physicians to prevent blood clots and to protect from strokes. However, the drug can cause irreversible internal bleeding that can quickly lead to death. Lawsuits have been filed against Bayer claiming that the company knew about the dangers with Xarelto and failed to properly warn the public. Those that have been affected by Xarelto want the drug taken off the market immediately.
What is Xarelto?
Xarelto (rivaroxaban) is one of the latest anti-coagulation, or blood thinning, medications approved for use by the FDA. The drug is an oral medication developed by Bayer and Johnson & Johnson. Blood thinning medication works by preventing dangerous blood clots that can move throughout the body and cause an obstruction of blood flow to the vital organs. The older anti-coagulation medications require a physician to prescribe a precise dose for each patient leading to extensive monitoring. Xarelto is a new type of anti-coagulant that is prescribed in one uniform dose making it an attractive alternative for both patients and doctors.
The Food and Drug Administration (FDA) approved Xarelto to reduce the risk of strokes in patient’s suffering from AF and to reduce the risk of blood clots in patients that have recently had hip or knee surgery. The FDA continued to approve Xarelto for treatment of deep vein thrombosis (DVT) and pulmonary embolisms (PE).
One of the most deadly side effects when using Xarelto is uncontrolled bleeding. When internal bleeding occurs near a major organ, the blood flow to that organ becomes blocked and can cause severe damage to the organs ability to function. Internal bleeding can also cause pools of blood to form throughout the body causing a multitude serious health risks. Xarelto is an anti-coagulant meaning it prevents blood from clotting. Bleeding will continue to occur and cannot be stopped until the drug has been entirely eliminated out of the body.
Another oral anti-coagulant medication is Pradaxa (dabigatran etexilate), produced by Boehringer-Ingelheim, Bayer’s competitor. Xarelto and Pradaxa are used to treat the same conditions, but they work in different ways. Xarelto works by preventing a protein known as Factor Xa from developing. This prevents a secondary protein, thrombin, from forming. Pradaxa instead directly prevents thrombin from forming.
Current Anticoagulant Market
The current anti-coagulant market is estimated around $10 billion with only a few companies producing the medication. In the past, Warfarin, was accepted as the standard anti-coagulant. However, Warfarin involves strict alterations in diet and lifestyle as well as frequent checkups with a physician. Due to the complicated nature of Warfarin, drug companies began to develop newer oral medications such as Xarelto and Pradaxa as safe, convenient alternatives. However, convenience comes at a price. Warfarin costs $200/year whereas Xarelto costs nearly $3,000/year.
Xarelto Uses and Clinical Studies
Original FDA Approval
Xarelto was originally approved by the FDA for use as a blood thinner in patients recovering from hip replacement or knee surgery. The FDA continued to approve the drug for blood clots in patients with atrial fibrillation although their own panel disapproved of the use.
Comparison to Warfarin
In 2011, the New England Journal of Medicine published a study called “Rocket AF” where Xarelto was compared with Warfarin in patients suffering from AF. The FDA concluded that the study failed to demonstrate the effectiveness of Xarelto over Warfarin. Xarelto has also been linked to more abdominal bleeding than Warfarin, which has been on the market for over 50 years.
All blood thinners have a high risk of internal bleeding because of how they work. However, older drugs such as Warfarin have emergency reversal agents to prevent severe injury. Unfortunately, Xarelto was not developed with an antidote. Without an antidote there is not much that can be done to stop the bleeding except dialysis to cleanse the blood of the drug. In many cases Xarelto has failed to be removed from the body through dialysis leading to fatal injuries.
One of the most dangerous side effects of Xarelto is bleeding. There is no antidote to stop the bleeding, unlike Warfarin, which makes treating patients incredibly challenging. The manufacturer of Xarelto has yet to release information to doctors on how the problem should be treated. Without this crucial knowledge the number of deaths in the emergency room will continue to rise.
Xarelto has many other serious side effects. The FDA reports that some patients may actually develop an increased risk for blood clots when taking the medication. According to the Institute for Safe Medication Practices, patients who have undergone hip or knee replacement surgery are at the highest risk for developing blood clots. These blood clots can travel to the brain and cause a heart attack or stroke. Patients that have had spinal injections are also at risk of developing blood clots in the spine, which can lead to permanent paralysis
Xarelto’s side effects include:
Abnormal Liver Function
Reduced Platelet Levels
Studies Link Xarelto to Wound Infections, Complications
Orthopedic surgeons across the country have observed a pattern in their patients taking Xarelto after having hip or knee replacement surgery. Many patients go through a secondary surgery to remove implants and undergo intense antibiotic therapy due to wound infections and leakage.
A study in the Journal of Bone and Joint Surgery linked Xarelto to these new complications in 2012. The study consisted of 13,000 patients who had undergone hip or knee surgery and subsequently took either Xarelto or Heparin. The patients that had taken Xarelto were 4x more likely to have wound complications than those that had taken Heparin.
In 2012 a study was presented at the American Academy of Orthopaedic Surgeons showing a significant increase in patients taking Xarelto after surgery and immediately returning to surgery within 30 days. Due to the severity of the wounds, doctors stopped prescribing Xarelto and instead gave their patients a script for an older anti-coagulant known as Tinzaparin.
Doctors advocate that those suffering with liver or kidney problems, and those who are pregnant or breastfeeding, should not take Xarelto. Patients that have had spinal injections, epidurals or surgery on the spine should not take Xarelto either. If taken after a spinal surgery there is an increased risk in forming blood clots in the spine leading to permanent paralysis. The risk of blood clots forming in the spine increases even more for those that take NSAIDS and ibuprofen.
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- Institute for Safe Medication Practices (ISMP) “QuarterWatch Monitoring FDA MedWatch Reports – Anticoagulants the Leading Reported Drug Risk in 2011 – May 31, 2012 – New Data from 2011 Quarters 3 – 4” http://www.ismp.org/quarterwatch/pdfs/2011Q4.pdf (Accessed June 2015)
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- Pierson, R. (2012, June 14). Insight: Top heart doctors fret over new blood thinners. Reuters. Retrieved from http://www.reuters.com/article/2012/06/14/us-drugs-bloodthinners-idUSBRE85D06G20120614
- Ansell, J. (2007). Factor Xa or thrombin: is factors Xa a better target? Journal of Thrombosis and Heamostasis, 5 (Suppl. 1): 60–4.
- U.S. Food and Drug Administration. (2012, November 2). FDA expands use of Xarelto to treat, reduce recurrence of blood clots. [Press release]. Retrieved fromh ttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm326654.htm
- Nguyen, A. (2012, May 29). Advisory panel recommends against anticoagulant drug approval. Wolters Kluwer Law and Health. Retrieved from http://health.wolterskluwerlb.com/2012/05/advisory-panel-recommends-against-anticoagulant-drug-approval/
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Wound Complications Following Rivaroxaban Administration
- Jaeger M, Jeanneret B, Schaeren S. “Spontaneous spinal epidural haematoma during Factor Xa inhibitor treatment (Rivaroxaban).” Eur Spine J. 2012 Jun;21 Suppl 4:S433-5.
- Patel MR, Mahaffey KW, Garg J, et al; and the ROCKET AF Steering Committee, for the ROCKET AF Investigators. “Rivaroxaban versus warfarin in nonvalvular atrial fibrillation.” N Engl J Med. 2011;365(10):883-891.
Institute for Safe Medication Practices (ISMP) “ISMP List of High-Alert Medications in Acute Care Settings” https://www.ismp.org/tools/highalertmedications.pdf (Accessed June 2015)