On April 23, the FDA issued a drug safety communication, alerting the medical community and patients about the risk of rare, but serious, neurological problems that can occur after receiving injections of corticosteroids into the epidural space of the spine. The agency says it will require new label warnings for all such injections.
The FDA began reviewing the safety of the injections after medical professionals raised concerns, reporting serious events that have included death, spinal cord infarction, full and partial paralysis, blindness, strokes, seizures, nerve injuries and brain edema.
The agency says that while many patients recovered within minutes to 48 hours after the injections, many patients have never recovered from the epidural steroid injection problems.
Epidural corticosteroid injections are used in the pain management industry to treat neck and back pain, but the FDA has never approved them for that purpose. The agency also warns that they are not proven safe or effective in treating pain.
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