Epidural Steroid Injections to Get New Warning Label

In late April, the FDA issued a safety announcement cautioning that corticosteroids delivered by epidural injection to treat back and neck pain may cause “rare but serious adverse events”–including vision loss, stroke, paralysis, and death. The agency is requiring an additional label warning to increase awareness of the risks, which were confirmed after the FDA reviewed cases from its Adverse Event Reporting System. Although anesthesiologists, physiatrists, and specialists other than orthopaedic surgeons often administer such injections, orthopaedists should note that as far as the FDA is concerned, the safety and efficacy of epidural steroid injections for neck and back pain have not been established. The FDA said it plans to convene an advisory committee later this year to “discuss the benefits and risks of epidural corticosteroid injections and to determine if further FDA actions are needed.”

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