The FDA’s April warning that use of epidural steroid injections (ESIs) may result in “rare but serious adverse events, including loss of vision, stroke, paralysis and death” has drawn a strong response from societies whose members offer the treatments. The FDA required the addition of a warning to the labels of injectable corticosteroids to describe these risks. The FDA also declared on April 23rd that the effectiveness and safety of ESI use has not been established. Several organizations, including the International Spine Intervention Society (ISIS) and the American Society of Interventional Pain Physicians, issued responses to the FDA in which they indicted the fact that all epidural steroid injections “regardless of technique” were criticized as potentially unsafe and ineffective. The FDA has countered that the warnings stem from an independent review board.
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