New Warnings for Epidural Steroids
According to Medscape, the U.S. Food and Drug Administration has ordered that injectable corticosteroids carry a new label warning addressing serious adverse events, including death, stroke, and permanent blindness and paralysis.
About the Label Change
Epidural injections of corticosteroids have seen widespread, off-label use as a treatment for pain, but the FDA is now warning that such uses can result in severe side effects.
In an announcement, the FDA warned anesthesiologists and pain management physicians that it has not yet established the effectiveness and safety of epidural corticosteroids such as methylprednisolone and hydrocortisone.
The agency also said that it began investigations into possible neurological risks at the request of concerned clinicians. Upon reviewing data from the FDA Adverse Event Reporting System (FAERS), the agency noted reports of temporary side effects, as well as more serious adverse events from which patients did not recover.
As a result, the FDA is now advising that clinicians discuss both the benefits and risks associated with epidural corticosteroid injections and inform patients of alternative therapies.
Additional Side Effects of Corticosteroids
According to DrugCite, the following adverse events have also been reported to the FDA:
- Pain in extremity
- Musculoskeletal pain
- Respiratory failure
- Renal Failure