An FDA advisory committee is meeting today to discuss adverse neurologic effects following the use of epidural steroid injections for pain management. Regulators, stakeholders, and pain management experts will gather at the FDA White Oak conference center in Silver Spring, Md., to discuss the safety of injectable corticosteroids, among other topics. While the FDA has not approved injectable corticosteroids for use through epidural injection, the products continue to be used off-label. The FDA does not regulate epidural injections, but it can regulate injectable medications generally. In April, after reviewing the medical literature and its own adverse event database, the FDA ordered a label warning for epidural injections to include the risks of severe adverse events (death, stroke, permanent blindness, and paralysis.) While these events are considered rare, the agent said the severity of potential outcomes warranted a written caution.
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