Injectable corticosteroids given via epidural to treat back and neck 
pain may cause “rare but serious” complications — paralysis, stroke, 
vision loss, and death — the FDA cautioned on Wednesday. The agency 
will require a label change to warn of these risks.

The warning follows a review of serious neurologic adverse events that 
occurred within minutes to 48 hours after epidural injections. Many of 
these complications were not reversible, according to the FDA report.

To date, the safety and efficacy of epidural corticosteroid injections 
have not been proven, says the agency, which also notes that 
corticosteroids have not been approved for this indication despite 
their widespread use. An advisory committee will meet later this year 
to discuss the benefits and risks of epidural injections.

FDA MedWatch safety alert