The US Food and Drug Administration (FDA) examined health records to determine neurologic risk factors of using epidural glucocorticoid injection and found 90 serious—and sometimes fatal—cases between 1997 and 2014 reported to the FDA Adverse Event Reporting System (FAERS).
Adverse effects such as paraplegia, quadriplegia, spinal cord infarction, and stroke have all been reported from epidural glucocorticoid injections. These events can be caused by technique-related problems like intrathecal injection, epidural hematoma, spinal cord injury, and embolic infarction, the researchers determined. Other procedural factors that may influence these events include the level of spinal injection, the method used to approach the epidural space, and degree of sedation.
“There is concern that in glucocorticoids formulated as suspensions rather than solutions, particulate matter may pose an increased risk of embolism after inadvertent intravascular injection,” Judith A. Racoosin, MD, MPH, the deputy director of safety in the FDA’s division of anesthesia, analgesia, and addiction products, and colleagues wrote in the New England Journal of Medicine. “All catastrophic events (those resulting in permanent disability or death) reported to FAERS were associated with injection of a suspension, whereas only a few cases involving temporary symptoms were reported with glucocorticoid solutions.”
The FDA analyzed healthcare claims data from IMS Health and Medicare to evaluate the use of glucocorticoid injections. In 2013, there were more than 1.3 million epidural glucocorticoid injections performed in 426 000 Medicare patients aged 65 years or older. For patients younger than 65 years, 604 000 injections were performed.
From 2009 to 2013, the FDA found use of solutions for injections increased from 5% to 15% in patients younger than 65 years, thereby increasing safety concerns. In 2013, 80% of the commercial products used were suspension formulations.
In 2011 the FDA established the “Safe Use Initiative” to help those who perform these procedures develop methods to minimize the risk of neurologic events. In 2014 the FDA ruled that all glucocorticoid injections must have a label warning users of neurologic risk. The warning did not recommend a method of approach, location of spinal injection, or formulation, because the FDA determined that each of these factor issued some risk for neurologic injury.
In November 2014 the FDA held an advisory committee to discuss adding regulations on the warning for epidural glucocorticoid injection, but decided that a population study should be conducted before more specific recommendations can be made against using suspensions.
“Patient selection may be the key to optimizing the efficacy of epidural glucocorticoid injection, and we encourage the medical community to work to identify the types of patients who might benefit most,” the researchers concluded.
- Racoosin JA, Seymour SM, Cascio L et al. Serious Neurologic Events after Epidural Glucocorticoid Injection—The FDA’s Risk Assessment. N Engl J. 2015; doi: 10.1056/NEJMp1511754.