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blog:bpaddock:fda_requires_label_changes_to_warn_of_rare_but_serious_neurologic_problems_after_epidural_corticosteroid_injections_for_pain [2014/05/31 02:10] (current)
bpaddock Added link to FDA safety anouncment.
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 +====== FDA requires label changes to warn of rare but serious neurologic problems after epidural corticosteroid injections for pain ======
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 +http://​www.fda.gov/​Drugs/​DrugSafety/​ucm394280.htm
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 +"​Safety Announcement
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 +[04-23-2014] The U.S. Food and Drug Administration (FDA) 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. We are 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.
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 +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. 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.1 This concern prompted us to review cases in the FDA Adverse Event Reporting System (FAERS) database and in the medical literature (see Data Summary).2-16
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 +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.
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 +As part of FDA’s ongoing effort to investigate this issue, we plan to convene an Advisory Committee meeting of external experts in late 2014 to discuss the benefits and risks of epidural corticosteroid injections and to determine if further FDA actions are needed.
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 +Injectable corticosteroids include methylprednisolone,​ hydrocortisone,​ triamcinolone,​ betamethasone,​ and dexamethasone. This safety issue is unrelated to the contamination of compounded corticosteroid injection products reported in 2012."
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 +~~DISCUSSION~~