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Xarelto and FDA Approval

Xarelto is an anticoagulant drug approved by the Food and Drug Administration (“FDA”) for three primary uses—to treat patients who are at risk of developing blood clots after knee or hip replacement surgery, to treat those who are at risk of strokes, pulmonary embolism, and deep vein thrombosis and those who are experiencing atrial fibrillation. The Food and Drug Administration did not approve Xarelto to treat all three health conditions at once. The FDA approved Xarelto as treatment for each concern after some research and time.

In July of 2011, the FDA approved Xarelto as a way to reduce the risk of blood clots that may happen after knee or hip replacement surgery. The news release stated that Xarelto should be taken once a day for 12 or 35 days, depending on the type of surgery that was preformed. In November of 2011, the FDA allowed Xarelto to be prescribed to patients who have an abnormal heart beat, also known as atrial fibrillation. Atrial fibrillation occurs when the beatings of the two upper heart chambers are irregular; this leads to blood pooling in the heart’s upper chambers. The pools of blood, or blood clots, travel to the brain and block the blood flow which leads to a stroke. Xarelto can prevent the blood clots, which ultimately prevents the risk of a stroke from occurring. Therefore, the risk of a stroke is reduced in patients taking Xarelto who have atrial fibrillation. In November of 2012, the FDA approved the use of Xarelto to treat deep vein thrombosis and pulmonary embolism. Deep vein thrombosis, also known as DVT, occurs when a blood clot forms in a vein deep within the body. The blood clot has the possibility to break off and travel to an artery in the lungs, blocking the flow of blood. This deadly process is called pulmonary embolism, also known as PE.

To date, thousands of Xarelto lawsuits are filed against the manufacturers and distributors of Xarelto which consist of Bayer, Janssen Pharmaceuticals and Johnson & Johnson, for misleading the public about this dangerous anticoagulant drug. One of the main side effects of Xarelto is severe internal bleeding. There is no effective way to stop the bleeding, which can result in death. The lawsuit alleges that the Xarelto manufactures knew of the potential side effects and knew that there was no treatment, reversal agent or antidote to stop the bleeding.

Legal Commentary

Xarelto attorneys within our firm are studying, examining and investigating current Xarelto claims on behalf of people or families injured by Xarelto. Some of the side effects include hemorrhaging, internal bleeding, stroke and or death. If you or a loved one has experienced any side effects while taking Xarelto, contact our Xarelto lawyers to discuss the facts of your potential case. We are available by phone for a Free consultation at 1.866.705.7584 or by email at

About the Author

Majed Nachawati is a preeminent Xarelto Lawyer with a focus on representing victims and families harmed by this dangerous drug on a nationwide basis. Mr. Nachawati has resolved numerous dangerous drug medication cases through trial and settlement that have resulted in seven and eight figure confidential settlements. He is on the Grievance Committee for the State Bar of Texas. He is licensed to practice in the Northern, Southern, and Eastern Districts of Texas. Mr. Nachawati is a member of the Board of Directors of the Texas Trial Lawyers Association, the Board of Directors for Public Justice, a Leaders’ Forum and PAC member of the American Association for Justice. Mr. Nachawati has been recognized as a Super Lawyer in Texas Monthly Magazine for the past six consecutive years for legal excellence, in connection with noteworthy settlements for pharmaceutical injury cases. Mr. Nachawati is also a member of The Million Dollar Advocates Forum. Mr. Nachawati can be reached by email at or by calling 1.866.705.7584.

Drug Litigation