Published: Apr 23, 2014
By John Gever, Deputy Managing Editor, MedPage Today
Injectable corticosteroids must now carry a new label warning about the risks of severe adverse effects from epidural injections including death, stroke, and permanent blindness and paralysis, the FDA said.
The agency decided that such a warning is needed after reviewing numerous reports in the medical literature and its own adverse event database.
“Serious adverse events included death, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, stroke, seizures, nerve injury, and brain edema,” the FDA said in announcing the warning.
“Many cases were temporally associated with the corticosteroid injections, with adverse events occurring within minutes to 48 hours after the corticosteroid injections. In some cases, diagnoses of neurologic adverse events were confirmed through magnetic resonance imaging or computed tomography scan. Many patients did not recover from these reported adverse events.”
Overall, the agency said, these events were rare, but their seriousness merited the label change.
It urged healthcare providers to discuss the risks with patients before giving injections and to instruct them to watch for adverse neurological effects such as loss of vision, numbness or tingling, severe headaches, or seizures.
The FDA emphasized that the warning is unrelated to the fungal contamination problem associated with steroids used in epidural injections in 2012 that resulted in a crackdown on compounding pharmacies.