The Food and Drug Administration (FDA) has issued an Order requiring injectable corticosteroids carry a warning label about the risks of severe adverse effects from epidural injections. Corticosteroids injections into the spine’s epidural space may in rare cases cause death, stroke, permanent blindness, and paralysis. Corticosteroids injections have been commonly used to treat radiating back or neck pain.
The FDA decided that this warning was necessary because of the number of reports to its own Adverse Event Database and the numerous reports of injury in the medical literature. In announcing the warning requirement, the FDA said that “serious adverse events included death, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, stroke, seizures, nerve injury, and brain edema.”
The FDA noted that the these events are rare, but their seriousness necessitated the label warning requirement.
In 2012, a fungal contamination problem associated with steroids used in epidural injections resulted in a crackdown on compounding pharmacies.