The Food & Drug Administration is warning that injections of corticosteroids into the spine's epidural space -- an extremely common treatment for radiating back or neck pain -- in rare cases may result in loss of vision, stroke, paralysis and death.
And that's even in the absence of fungal and other contamination introduced by compounding pharmacies that killed 48 people in 2012 and 2013.
Physicians offering these injections to patients with back or neck pain should discuss these rare but serious risks with patients considering a jab of steroidal medication into the cerebrospinal fluid, the FDA said Wednesday.
The warnings mark the opening volley of an FDA effort to improve the safety of a pain treatment that thrives in medical practice without ever having received the agency's formal blessing. While many patients and physicians swear by the treatment for back and neck pain, the use of corticosteroids injected into the spinal space has never been shown safe and effective in clinical trials assessed by the FDA.
Later this year, the drug-safety agency said it will convene an advisory panel to discuss the risks and benefits of such injections and explore whether further regulation would reduce injuries from this use of injected methylprednisolone, hydrocortisone, triamcinolone, betamethasone and dexamethasone. An expert panel of pain specialists convened by the FDA has drafted a slate of recommendations to minimize possible harms from this specific use of corticosteroids, and the FDA says it will release those guidelines when they're finalized.