FDA Adds Warning to Corticosteroid Injection Labels

WASHINGTON – Corticosteroid injections given to treat neck and back pain, as well as radiating pain in the arms and legs, can have rare but serious adverse effects, according to the Food and Drug Administration (FDA).

Noting that those side effects can include loss of vision, stroke, paralysis, and death, the FDA said it is requiring the addition of a warning to the drug labels of injectable corticosteroids to describe those risks.

“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,” the agency pointed out in a drug safety communication. “We started investigating this safety issue when we became aware of medical professionals’ concerns about epidural corticosteroid injections and the risk of serious neurologic adverse events. This concern prompted us to review cases in the FDA Adverse Event Reporting System (FAERS) database and in the medical literature.”

More actions could be taken, as the FDA is convening an Advisory Committee meeting of external experts in late 2014 to discuss the benefits and risks of epidural corticosteroid injections and to determine if other cautions need to be issued.

The FDA also has convened a panel of experts, including pain management specialists, to help define the techniques for such injections to reduce preventable harm. The expert panel’s recommendations will be released when they are finalized.


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