Xarelto Recalls & FDA Warnings

At this point in time, Xarelto has not been recalled by the Food and Drug Administration, but since its release in 2011 the agency has issued several important safety warnings, including two “black box warnings”. These black box warnings are the strictest warnings that the FDA can issue to a drug short of recalling it.  These warnings usually mean that there is “reasonable evidence” of a hazard associated with taking the drug.

Related Reading: Miralax Side Effects: Are Children At Risk Of Seizures?

Timeline of Xarelto Warnings

In August 2013, the FDA announced its first black box warning for Xarelto.  The black box warning stated that patients who prematurely discontinued Xarelto usage were at a higher risk for blood clots, deep vein thrombosis, and epidural/spinal hematoma.

Bleeding Risks Highlighted In FDA Safety Announcement

A few months later in January 2014, a “warning/precaution” was issued by the FDA in regards to Xarelto and Rivaroxaban, the generic form of the drug, stating that they were aware of the bleeding risk associated with these medications.  The warning went on to recommend blood transfusions or replacement if a patient experienced blood loss while taking Xarelto.

This warning also discussed that there is no reversal agent or antidote for Xarelto.  With most other blood thinners, a doctor can administer vitamin K or protamine sulfate to counteract the anticoagulant properties of a blood thinner in an emergency situation.  Neither of these antidotes will work with Xarelto though because Xarelto blocks Thrombin.

Epidural & Spinal Puncture Patients

Not too long after that, in March 2014 the FDA issued their second black box warning for Xarelto.  This warning was in regard to patients who were undergoing an epidural (spinal anesthesia/analgesia) or spinal puncture.  The warning directed that if a person taking Xarelto needed to undergo this procedure that they wait until Xarelto has been flushed from their system.

Thrombocytopenia

The next warning for Xarelto came in December 2014 when the FDA issued an “Adverse Reaction” report on Xarelto. This report was in regards to a condition called thrombocytopenia and warned that Xarelto may be a cause of it.  Thrombocytopenia is when the body suffers from low blood platelet counts and can result in internal bleeding because blood platelets are crucial in the formation of blood clots.

This FDA report also changed the description of an adverse reaction from “cytolytic hepatitis” to “hepatitis”, including hepatocellular injury, a major liver injury.

Dangerous Drug Interactions

The FDA issued another warning in December 2014 regarding drug interactions with Xarelto.  The warning listed several drugs that should not be taken with Xarelto.  The complete list of drugs is below:

• Itraconazole – Sporanox and Onmel
• lopinavir – Kaletra
• Ritonavir – Norvir
• Indinavir – Crixivan
• Conivaptan – Vaprisol
• Carbamazepine – Tegretol, Tegretol-XR, Equetro, Carbatrol, Epitol, and Teril
• Phenytoin – Dilantin
• Rifampin – Rifater, Rifamate, Rimactane, and Rifadin
• St. John’s wort – Hypericum Perforatum

In addition, the FDA warned that Xarelto has not been tested in patients who have a prosthetic heart valve, and warned that as a result, Xarelto should not be taken by such patients.