FDA Warns of Neurological Risks With Epidural Steroids

April 23, 2014

The FDA has issued a safety alert warning that epidural corticosteroid injections may rarely cause serious neurological adverse events including loss of vision, stroke or paralysis, or may be fatal.

The Food and Drug Administration today issued a safety alert warning that epidural injection of corticosteroids may cause "rare but serious" neurological sequelae such as vision loss, stroke, or paralysis, or may even be fatal.

FDA notes that epidural injection of corticosteroids for back and neck pain and pain that radiates to the arms and legs are not approved by the Agency, and that their effectiveness and safety have not been established.

FDA has mandated the addition of a warning about these risks to the labels of injectable corticosteroids.