FDA News

FDA warns of serious neurological problems after epidural corticosteroid injections, calls for label change

The FDA issued a warning that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events that include loss of vision, stroke, paralysis and death. The injections are usually performed to treat neck and back pain or radiating pain in the arms and legs, or to reduce swelling or inflammation.

According to the safety announcement from the FDA, it is requiring a “warning” be added to the labels of injectable corticosteroids, such as methylprednisolone, hydrocortisone, triamcinolone, to alert users of these risks. The agency urged patients to discuss the benefits and risks of epidural corticosteroid injections, as well as other treatments, with their health care professionals.

Although these injections are commonly used, the effectiveness and safety of the drugs for this practice have not been established and the FDA has not approved corticosteroids for such use, as noted in the announcement.

The FDA said it began to investigate this safety issue when it became aware of medical professionals’ concerns about the potential risk of serious neurologic adverse events with epidural corticosteroid injections.

The FDA Safe Use Initiative formed a panel of experts to help define the techniques for such injections that would reduce preventable harm and the panel’s recommendations will be released when they are finalized. Furthermore, as part of its ongoing investigation into this situation, the FDA plans to convene an Advisory Committee meeting later this year to determine if further FDA actions are needed.