Another direct competitor of Xarelto is the oral anticoagulant medication Pradaxa (dabigatran etexilate) produced by Boehringer-Ingelheim. Xarelto and Pradaxa are used to treat the same conditions, but they work in different ways. Xarelto (rivaroxaban) 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 these medications. 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 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 – The Original FDA Approval
The US regulatory agency granted its approval to rivaroxaban to prevent the formation of blood clots in patients who underwent joint replacement surgery. Later the medication’s indications were expanded to include the prevention of the risk of stroke in atrial fibrillation patients. The original panel, however, recommended against the approval of this indication.
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 rivaroxaban over Warfarin. The newer blood thinner has also been linked to more abdominal bleeding than Warfarin, which has been on the market for over 50 years.
All anticoagulants are linked to a serious risk of internal hemorrhages because of their mechanism of action. While the effects of older medicines including Warfarin can be reverted, though, the absence of an antidote for Pradaxa and Xarelto prevents doctors from saving a patient’s life once a bleeding accident occurs. Not even dialysis can remove the drugs from the patient’s drug, causing a dangerous reaction which may have lethal consequences.
Side Effects of Xarelto
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 this drug 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 of 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 of developing thrombi. These blood clots can travel to the brain and cause a heart attack or a stroke. Patients that have had spinal injections are also at risk of developing blood clots in the spine, which can lead to permanent paralysis
Rivaroxaban side effects include:
- Abdominal Bleeding
- Brain Hemorrhage
- Abnormal Liver Function
- Reduced Platelet Levels
Studies link Xarelto to wound infections and post-surgical 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. Pradaxa, on the other hand, was never associated with this type of risk.
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 rivaroxaban or a heparin. The patients that had taken Xarelto were four times more likely to have wound complications than those that had taken a heparin.
In 2012 a study was presented at the American Academy of Orthopaedic Surgeons showing a significant increase in patients taking the infamous anticoagulant after surgery and immediately returning to surgery within 30 days. Due to the severity of the wounds, doctors stopped prescribing rivaroxaban and instead gave their patients a script for an older anticoagulant known as Tinzaparin.
Doctors advocate that those suffering from liver or kidney problems, and those who are pregnant or breastfeeding should not take Xarelto or Pradaxa. Patients that have had spinal injections, epidurals or surgery on the spine should not take this drug either. If taken after a spinal surgery there is an increased risk of blood clots forming in the spine leading to permanent paralysis. The risk of spinal thrombi spine increases even more for those that take NSAIDS and ibuprofen.
Article written by: Dr. Claudio Butticè, Pharm.D.
Last Updated: 2016/08/23