Why does Xarelto’s label contain a “black box” warning?

By: Ani Barsamian, JD

A “black box” warning is the FDA’s most serious kind of warning.  Xarelto’s label includes two “black box” warnings on its label to inform users of the serious risks associated with using the drug.  The first warning alerts patients that receiving spinal anesthesia (epidural) or undergoing spinal procedures (spinal tap) while taking Xarelto can cause paralysis.  The second warning informs users with nonvalvular atrial fibrillation that the discontinued use of Xarelto may increase the risk of blood clots and strokes in those patients.