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Skip to main content reports on the various warnings that have been issued by the FDA regarding the anticoagulant drug Xarelto since its release in 2011. When first approved Xarelto was intended to be taken to prevent deep vein thrombosis, pulmonary embolism, and blood clots after hip or knee replacement. Its approved use was later expanded to include the treatment of atrial fibrillation, a common heart condition.

The Timeline Of FDA Warnings Issued

The first black box warning was issued in August of 2013. This warning stated that a premature discontinuation of the drug could increase the risk of blood clots, deep vein thrombosis, and epidural/spinal hematoma. Just a few months later in January of 2014, the FDA released another warning regarding Xarelto and rivaroxaban, the generic form of the drug, stating that there are bleeding risks associated with taking the blood thinner. The FDA also recommended blood transfusions in the event of bleeding emergency due to the lack of an available antidote.

Following the January warning, the FDA issued a second black box warning in March 2014 for Xarelto. This warning addressed the danger present for patients who were scheduled to undergo an epidural or spinal procedure and advised these individuals to wait until the drug was completely out of their system before the procedure is completed to reduce the risk of bleeding.

In December of 2014 another warning was issued regarding thrombocytopenia. The agency warned that Xarelto could cause the condition which is when the body suffers from low blood platelet counts. This can result in internal bleeding because platelets are critical in the formation of blood clots. There was a second warning released in the same month regarding the various drug interactions that could occur with Xarelto, and should not be taken with the drug.

Thousands Of Lawsuits Filed

During the short period of time that the drug has been on the market, thousands of lawsuits have been filed alleging life-threatening and sometimes fatal side effects. Furthermore, many of the lawsuits allege that the manufacturers were negligent because they failed to warn consumers about the risks involved with taking the drug. Over 3,000 federally-filed cases have been consolidated into MDL 2592 and a mass tort program has been created in Philadelphia, PA housing over 600 cases.

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