FDA Warns of Neurological Risks Linked to Epidural Corticosteroid Injections

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The US Food and Drug Administration is now requiring the drug labels of corticosteroids injected into the epidural space of the spine to include a warning on the risk of loss of vision, stroke, paralysis, and death.

The US Food and Drug Administration (FDA) has required a drug label change for injectable corticosteroids to include a warning on the rare yet serious risks of loss of vision, stroke, paralysis, and death.

The FDA noted in a press release the effectiveness and safety of corticosteroids injected into the epidural space in the spine have not been established, so the agency has not approved the analgesics for this indication. Nevertheless, epidural corticosteroid injections are used to treat neck and back pain that echoes in the arms and legs.

The FDA panel that released the recommendation was comprised of pain management experts, among others. The panel will next convene to create and define techniques for epidural corticosteroid injections, which would reduce preventable harm. An FDA Advisory Committee will also meet later this year to determine whether further federal action is necessary in regards to injectable corticosteroids.

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