Serious Neurologic Events after Epidural Glucocorticoid Injection — The FDA's Risk Assessment

Abstract

At times, the Food and Drug Administration (FDA) must grapple with safety concerns related to off-label uses of FDA-approved medications. Over the past several years, we have sought to understand the risk of serious neurologic events that occur after the epidural injection of glucocorticoids (corticosteroids) - a procedure that is commonly performed in the United States in an effort to manage radicular neck and back pain. The FDA has not approved any injectable glucocorticoid product for epidural administration, so any such use is considered off-label - part of the practice of medicine and not regulated by the FDA. In 2009, . . .