ISSUE: NOVEMBER 2014 | VOLUME: 12(11)
The FDA’s warning that use of epidural steroid injections (ESIs) may result in “rare but serious adverse events, including loss of vision, stroke, paralysis and death” drew a strong response from societies whose members offer such pain 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 23 that the effectiveness and safety of ESI use has not been established. The International Spine Intervention Society (ISIS), an association of physicians dedicated to the diagnosis and treatment of spine pain, responded with the following statement on their website’s home page: “ISIS feels that the alert was misleading in its message regarding the safety of epidural steroid injections and contained inaccuracies regarding the effectiveness of this procedure.”
The American Society of Interventional Pain Physicians also issued a response critical of the FDA warning. Additionally, although not addressing the FDA alert directly, the Multi-Society Pain Working Group, of which ISIS is a member, issued a set of 17 recommendations regarding ESIs.
“All epidural injections regardless of the technique were similarly affected and impugned in the released [FDA] statement,” said Jeff Summers, MD, president of ISIS. “The literature suggests that epidural steroid injections are both safe and efficacious in certain circumstances. … In terms of efficacy there is considerable evidence to support, for example, lumbar transforaminal ESI. There are good studies, including randomized controlled trials, to that effect. We also feel similarly that the evidence suggests that the use of nonparticulate steroids significantly lowers the risk for catastrophic neurologic injury due to inadvertent intra-arterial injection. To my knowledge, there has never been a catastrophic neurologic event that has been directly attributed to a nonparticulate preservative-free steroid.”
Dr. Summers said items such as nonparticulate preservative-free dexamethasone should not have been included in the FDA statement “cautioning about the inherent risk for catastrophic neurologic events with steroid injections.” He said the effectiveness of ESIs for certain conditions are well established in the literature—such as transforaminal ESI in treating radicular low back pain due to disk herniation.
In response to the ISIS statement, John Whyte, MD, MPH, director of Professional Affairs and Stakeholder Engagement Staff (PASES), which addresses issues and concerns regarding drug development, safety and review, wrote by email: “There are a variety of complexities that must be considered in evaluating the safety of ESI. FDA/CDER [Center for Drug Evaluation and Research] is taking the issue to an advisory committee to further discuss these complexities and determine if additional actions are needed.”
ISIS members took issue with the alert being sent through the FDA’s regulatory division and not the Safe Use Initiative (SUI), an expert panel convened to develop recommendations for ESI.
“The expert panel convened by the FDA SUI has not completed its recommendations. This panel is independent of the FDA,” Dr. Whyte said. “The [FDA] determined that action was necessary to make health care providers and patients aware of this safety issue. This determination was made by CDER, and the SUI team was aware.”
—George Ochoa
Drs. Summers and Whyte did not report any relevant conflicts of interest.