Though it was FDA approved in 2011, many people who have taken Xarelto have claimed bleeding in lawsuit filings around the country. This anticoagulant medication, known by its generic name rivaroxaban, is a powerful blood thinner that is prescribed to people with cardiovascular problems. However, many respected heart doctors are worried that the drug is not safe for use. They compare rivaroxaban to Pradaxa, a similar medication that has been blamed for dozens of fatal events.


This drug is often used to reduce the chance of stroke in patients suffering from atrial fibrillation. The medication is also effective at reducing the likelihood of deep venous thrombosis.

There are many patients, though, who either do not benefit from its use or whose condition may worsen if the medication is administered. This includes patients with heart valve disease, patients with mitral valve stenosis, those with a heart valve implant, or people who have suffered from acute coronary syndrome in the recent past. In these patients, rivaroxaban may be ineffective or result in complications that put the patient in mortal danger.


There have been hundreds of adverse reports involving Xarelto and bleeding. Most lawsuit filings have cited intestinal, rectal or brain hemorrhaging as the primary injury. In many cases, this hemorrhaging resulted in the death of the patient.

These complications are particularly deadly because there is no clinically approved way of reversing the hemorrhaging in the event of a rivaroxaban overdose. All that can be done for these patients is to hospitalize and monitor them. Hemorrhaging typically lasts for around 24 hours after it first appears, so even if it is detected, it may already be too late to save the patient.


The FDA maintains a detailed database of all drug related adverse events, and blood thinners like rivaroxaban consistently rank among the deadliest medications on the market. In 2011, rivaroxaban was the 10th most dangerous drug, as it was involved in 151 fatal events. In other countries, the dangers associated with rivaroxaban are becoming a major concern. From January to August 2013 in Germany, for example, there were 72 fatal reports, and several hundred injury reports filed with German regulatory agencies. Many Europeans doctors, as a result, are no longer recommending this medication  as a first option in treatment. Officially, the safety of the drug is not known beyond two years of use, so even though it has been approved for use, there are still many questions regarding its safety.

Now that the link between Xarelto and bleeding is understood, lawsuit proceedings have begun around the country. Most of these cases accuse Bayer, the drug’s manufacturer, of not testing the medication enough before marketing it and concealing information about its safety record. The first cases were filed in June, and hundreds more are expected.