Epidural steroid injections must now carry new warning labels about the possible risks of serious adverse events, according to a new FDA announcement issued last week, as reported by Medpage Today.
“Injecting corticosteroids into the epidural space of the spine has been a widespread practice for many decades; however, the effectiveness and safety of the drugs for this use have not been established, and FDA has not approved corticosteroids for such use,” the agency wrote in a recent safety announcement.
After an analysis of the medical literature and its own database, the agency decided that although serious risks of epidural steroids are rare, they are severe enough to require a warning label. Rare serious adverse events include stroke, paralysis, loss of vision, and death.
The agency said its new warning is unrelated to an outbreak of fungal meningitis tied to contaminated epidural steroid injections from the New England Compounding Center in 2012-13.The outbreak led to 64 deaths and affected 751 patients who had received the injections for various spinal injections, according to the CDC.
Earlier research has questioned the efficacy and safety of epidural steroid injections for the routine treatment of back pain, neck pain, and sciatica. Last year, a study from the Journal of Bone and Joint Surgery found that epidural steroid injections increased bone fragility in patients over the age of 50 years old. Each individual injection was associated a greater risk of vertebral fractures by a factor of 1.21.
A number of non-surgical options can provide back-pain relief without the risk of epidural steroid injections. When comparing chiropractic care to epidural nerve root injections, a study found that chiropractic patients actually had greater reductions in back pain and lower medical costs.