FDA requires warning of possible neurologic events after epidural corticosteroid injections

FDA is requiring that drug labels for injectable corticosteroids used to treat neck and back pain must be updated to include a warning of rare but serious adverse events, including vision loss, stroke, paralysis, and death, according to a recent FDA drug safety communication.

FDA urges patients to discuss the benefits and risks of these epidural injections with their healthcare providers as well as other alternative treatments. The injectable corticosteroids that require the warning include betamethasone, dexamethasone, hydrocortisone, methylprednisolone, and triamcinolone.

“This safety issue is unrelated to the contamination of compounded corticosteroid injection products reported in 2012,” according to FDA.

FDA started to investigate the safety of epidural corticosteroid injectables-which is not an FDA-approved use-when the agency became aware of healthcare providers’ concerns and the risk of neurologic events after the use of these drugs. FDA reviewed cases in its database of reported adverse events and in 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. The expert panel’s recommendations will be released when they are finalized,” FDA said.

Later this year, FDA plans to hold an advisory committee meeting with outside experts to further discuss the safety and efficacy of these epidural injections and to advise if any more action is needed.