Xarelto: Is Fatal Bleeding as Rare as the FDA Says?

More than thirteen million people have been prescribed Xarelto since it was introduced in 2011. Along with Pradaxa and Eliquis, it has quickly replaced Coumadin as one of the most commonly prescribed blood thinners. It thins blood so well, in fact, that thousands of users have reported serious bleeding events in recent years.

Is Xarelto safe?

Xarelto has been shown to be effective in preventing strokes and clots in patients with atrial fibrillation, deep vein thrombosis, and pulmonary embolism. But one of the most common side effects of Xarelto is hemorrhaging, or uncontrollable bleeding.
In fact, the Institute for Safe Medication Practices (ISMP) identified 680 reports of “serious adverse events” related to Xarelto use in just one quarter. 1
The danger of Xarelto is its lack of a reversal agent. Coumadin, for example, can be counteracted by vitamin K if a patient experiences significant bleeding. However, the newer class of blood thinners like Xarelto, Pradaxa, and Eliquis have no known reversal agent.2 Once a Xarelto user begins hemorrhaging, it can be difficult for doctors to stop the bleeding.

How does Xarelto work?

Xarelto is an anticoagulant, or blood thinner, that belongs to a class of drugs known as Factor Xa inhibitors. Factor Xa inhibitors prevent blood clots from developing by blocking the activity of the clotting factor Xa.
The drug is now widely prescribed for stroke and clot prevention in patients with atrial fibrillation, deep vein thrombosis or pulmonary embolism. It’s also used to prevent blood clots after hip and knee replacement surgeries.

What does the FDA say?

Although there is no known reversal agent, the FDA says it found the drug worthy of approval because it causes fewer intra-cranial hemorrhages than Coumadin.2 The FDA also says that most bleeding events associated with blood thinners aren’t life-threatening, and that fatal bleeding is “quite rare.”

What’s next?

Is fatal bleeding as rare as the FDA says it is? There are more than 400 lawsuits pending, most of which cite complaints of uncontrollable bleeding or death caused by uncontrollable bleeding as a direct result of Xarelto use.

The FDA says the benefit of using Xarelto to prevent strokes outweighs the increased risk of bleeding that it causes.2 But Xarelto-related bleeding events continue to be reported, many of them considered serious. Is the FDA just urging us to trade the risk of one life-threatening incident for another?

Know the signs of bleeding caused by Xarelto:

If you experience any of the following symptoms, contact your doctor immediately. Serious bleeding events can be fatal.

• Recurring nosebleeds
• Bleeding from the gums
• Coughing up blood or blood clots
• Vomiting blood or vomit that resembles coffee grounds
• Heavy menstrual bleeding
• Red, pink or brown urine
• Extreme dizziness or weakness