Washington, DC: The Food and Drug Administration (FDA) is warning that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death.
The injections are given to treat neck and back pain, and radiating pain in the arms and legs. The effectiveness and safety of epidural administration of corticosteroids have not been established, and FDA has not approved corticosteroids for this use, including methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone.
FDA is requiring the addition of a Warning to the drug labels of injectable corticosteroids to describe these risks.
To raise awareness of the risks of epidural corticosteroid injections in the medical community, the FDA' Safe Use Initiative convened a panel of experts, including pain management experts to help define the techniques for such injections which would reduce preventable harm. The expert panel' recommendations will be released when they are finalized. The FDA will convene an Advisory Committee meeting of external experts in late 2014 to discuss the benefits and risks of epidural corticosteroid injections and to determine if further FDA actions are needed.
