Xarelto (rivaroxaban) is a popular anti-clotting drug that is prescribed as a more convenient option than older anti-coagulants such as warfarin. Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson, tells consumers that Xarelto will free you from the routine blood monitoring necessary with older blood thinners and that it is the most prescribed blood thinner in its class. Xarelto can cause major bleeding events that cannot be controlled because there is no antidote, as well as other potentially fatal adverse events.
Xarelto Side Effects
Xarelto was approved by the U.S. Food and Drug Administration (FDA) in 2011. According to the Institute for Safe Medication Practices (ISMP) Quarter Watch 2012 Quarter 4 and Annual Report, the FDA received reports of 2081 adverse events involving Xarelto use, including 151 deaths, in 2012 alone.
Dangerous and deadly potential side effects of taking Xarelto include:
- Brain hemorrhage
- Gastrointestinal bleeding
- Rectal bleeding
- Excessive bleeding that cannot be controlled after an injury
- Development of blood clots
- Pulmonary embolism
- Deep vein thrombosis
- Abnormal liver function
- Reduced platelet levels
Why Xarelto Bleeding is so Dangerous
All anti-coagulants, including warfarin, increase your risk of having a major bleeding event. The difference is, with warfarin emergency room doctors can use Vitamin K to reverse the action of the drug so that clotting can resume and the bleeding can be stopped.
For Xarelto, and other similar blood thinners, there is no reversal agent. When a patient comes in bleeding, either spontaneously or from trauma, doctors are helpless to stop it and the patient can bleed out and die despite all efforts to save them.
So far, Xarelto has received FDA approval for three uses:
- July 1, 2011 – to prevent deep vein thrombosis (DVT) in patients undergoing knee or hip replacement surgery
- November 4, 2011 – to prevent stroke in people with a type of abnormal heart rhythm called non-valvular atrial fibrillation
- November 2, 2012 – to treat and prevent the recurrence of DVT and pulmonary embolism (PE), both of which are dangerous blood clots
Monitoring and Dosing
Xarelto’s main selling point is that it is easier to use for patients and doctors. The same dose is used in all patients, there is no routine monitoring and no dose adjustment based on monitoring. That is the advantage the new blood thinners are supposed to have over warfarin.
Studies have found that these drugs do not affect all patients the same. When patients were monitored the inhibition of blood-clotting varied greatly, meaning that monitoring and adjusting accordingly could reduce the risk of bleeding events in people taking Xarelto and similar drugs.
However, if Xarelto patients had to undergo monitoring like warfarin user do, it would undermine the marketing strategy that has made Xarelto so profitable. It could also mean that the benefits of taking Xarelto over warfarin would no longer outweigh the risks.