The FDA ( Food and Drug Administration ) is warning that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death.
The injections are given to treat neck and back pain, and radiating pain in the arms and legs.
FDA is requiring the addition of a Warning to the drug labels of injectable corticosteroids to describe these risks.
Patients should discuss the benefits and risks of epidural corticosteroid injections with their health care professionals, along with the benefits and risks associated with other possible treatments.
Injectable corticosteroids are commonly used to reduce swelling or inflammation. Injecting corticosteroids into the epidural space of the spine has been a widespread practice for many decades; however, the effectiveness and safety of the drugs for this use have not been established, and FDA has not approved corticosteroids for such use.
FDA started investigating this safety issue when the Agency became aware of medical professionals’ concerns about epidural corticosteroid injections and the risk of serious neurologic adverse events.
This concern prompted FDA to review cases in the FDA Adverse Event Reporting System ( FAERS ) database and in the medical literature.
To raise awareness of the risks of epidural corticosteroid injections in the medical community, FDA’s Safe Use Initiative convened a panel of experts, including pain management experts to help define the techniques for such injections which would reduce preventable harm.
Injectable corticosteroids include Methylprednisolone, Hydrocortisone, Triamcinolone, Betamethasone, and Dexamethasone. ( Xagena )
Source: FDA, 2014