A perspective in the New England Journal of Medicine discusses the FDA’s risk assessment of serious neurologic events associated with the off-label use of epidural glucocorticoid injections.
In April 2014, the FDA required a label change for injectable corticosteroids — which are commonly used to treat neck and back pain — to warn about “rare but serious,” and sometimes fatal neurologic complications, including paralysis and stroke. The action was in response to some 90 cases reported to the agency between 1997 and 2014. (The 2012 fungal meningitis outbreak associated with methylprednisolone was not included.)
Later in 2014, however, an advisory committee recommended against further regulatory action, which potentially included contraindications to restrict injections into the epidural space and for suspension formulations which may pose a greater risk than solutions.
The authors write that a population-based study is needed to “establish a valid estimate” of the event rate. They further note that available data don’t confirm solutions are safer than suspensions.
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