Although there is very little scientific data to guide practices, and more research is desperately needed, experts from across many medical disciplines could agree on some specific ways to improve safety. These guidelines were recently assembled and published.
“These are nothing more than expert opinions, but they are a starting place for all practitioners to think carefully about how we perform these injections and how we can improve their safety,” said Rathmell. “If practitioners adopt some simple techniques that we have assembled in one place in this publication, the incidence of these injuries is likely to decline. Epidural steroid injections are a valuable treatment for speeding the resolution of pain associated with acute disc herniation. The chances of adverse effects of any kind is low and can be made even lower through adopting some of these simple practices.”
FDA Regulatory Action to Ensure Safe Use
The FDA previously took regulatory action regarding ESIs on April 23, 2014, when the agency issued a Drug Safety Communication warning that injecting corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death.
Then on November 24 and 25, 2014, the FDA convened an Anesthetic and Analgesic Drug Products Advisory Committee Meeting to discuss the risk of serious neurologic adverse reactions associated with ESIs, the efficacy of ESIs, and the overall risk-benefit balance of injecting steroids in the epidural space to treat pain.2
“The Advisory Committee voted 15-7 (with one abstention) that they could envision a situation with ESIs that would warrant a contraindication in the labeling of injectable corticosteroids,” said Baumgartner. “The Advisory Committee deliberations will assist the agency in its discussions of possible regulatory options, including but not limited to, changes to the product labeling. However, the FDA has not taken further regulatory action at this time.”
According to James D. Artuso, MD, an anesthesiologist at Lancaster General Health in Lancaster, Pennsylvania, the adverse neurologic events associated with ESI are infrequent but devastating. Therefore awareness and education about safeguards to minimize any potential complications from this procedure are warranted.
1. Rathmell JP, et al. Safeguards to prevent neurologic complications after epidural steroid injections: Consensus opinions from a multidisciplinary working group and national organizations. Anesthesiology. 2015; 122: 974-984.
2. FDA: U.S. Food and Drug Administration. 2014 meeting materials, anesthetic and analgesic drug products advisory committee. Available at:. Accessed: May 19, 2015.