Xarelto is a specific type of Factor Xa inhibitor anticoagulant that has been on the market since the U.S. Food and Drug Administration (FDA) approved its use in 2011. The pharmaceutical company Bayer created the medication, and licensed the right to manufacture and market it to Johnson and Johnson affiliate Janssen.
Besides arthroplasty patients, Xarelto is prescribed to atrial fibrillation patients to help prevent strokes and other dangerous events that might result from blood clots, such as pulmonary embolism and heart attacks.
Unfortunately, Xarelto can at the same time produce a risk of serious internal bleeding, including hemorrhagic stroke, brain hemorrhage, and gastrointestinal bleeding. Some have referred to these injuries as an Xarelto Bleeding Injury.
In 2014, the U.S. FDA approved additional language for Xarelto’s package labeling to warn about some but not all of the risks of bleeding events, including discouraging use of the drug in some kidney patients, pregnant women, nursing mothers, and patients with heart valves. However, the label does not warn about wound infection risks or the lack of an antidote in the event of a hemorrhage.
To discuss a Xarelto Bleeding injury or other event, please call us at (800) 632-1404 or chat with us today.