Panel Urges Modification of Epidural Steroids

An advisory committee has urged the US Food and Drug Administration (FDA; Silver Spring, MD, USA) to modify labels of certain formulations of corticosteroids in an attempt to make epidural injections safer.

The FDA Anesthesia and Analgesic Drug Products Advisory Committee voted 15–7 in favor of calling particulate steroids contraindicated for epidural injection, because they appear to carry greater risk of adverse neurological effects than nonparticulate agents. The committee was convened in November 2014 following a number of reports of catastrophic injuries associated with patients receiving injectable corticosteroid injections to relieve back, neck, and radicular pain.
The panel also found that transforaminal injections—delivered at a spinal opening of a nerve root—are the greatest culprit in terms of epidural steroid injection risk. This was supported by an American Society of Anesthesiology (ASA; Schaumburg, IL, USA) closed claims reports that found 78 complications, 30 infarctions, and 13 instances of death following cervical transforaminal epidural steroid injections. And while there is some evidence that transforaminal injections may be more effective for pain reduction than the intralaminar or caudal approach, their proximity to an artery may also increase the risk of an embolic event.

“Animal studies have already demonstrated the risk of ischemia when particulate steroids are injected arterially,” said panel member associate professor of epidemiology, neurology, and anesthesia John Farrar, MD, PhD, of the University of Pennsylvania (Philadelphia, USA). “If you put particles into the bloodstream headed toward any structure you're going to cause ischemia. That's what leads ultimately to the infarction of the cord of the brain.”

Although needle penetration of the spinal cord can produce injuries, with a wide range of severity, injection of any material into the cord is invariably devastating. The vast majority of serious injuries related to cord trauma are associated with cervical epidurals. A conundrum is that while the risk of using particulate steroids is greater, there is little evidence that non-particulate (soluble) steroids have equivalent efficacy, and early studies indicate that soluble steroid preparations remain in the spinal canal only for brief periods.

Related Links:
US Food and Drug Administration
American Society of Anesthesiology