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