- 2015;18;E129-E138Safeguards to Prevent Neurologic Complications after Epidural Steroid Injections: Analysis of Evidence and Lack of Applicability of Controversial Policies
Health Policy Opinion
Frank JE Falco, MD, and Laxmaiah Manchikanti, MD.
After extensive debate and investigation by the Food and Drug Administration (FDA), Rathmell et al published the final document of Safeguards to Prevent Neurologic Complications after Epidural Steroid Injections. This is a product of consensus by 13 national organizations known as the Multisociety Pain Workgroup (MPW), excluding the American Society of Intervention Pain Physicians (ASIPP), an organization with mission and objectives to promote the development and practice of safe, high quality, cost-effective interventional pain management techniques. This article follows the warning issued by the FDA on April 23, 2014 hat the 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. This warning was issued without consensus or consultation of the safe use initiative (SUI) established by the FDA (3). Following this, significant controversy with multiple manuscripts and a citizen petition opposing the warning along with communication to the FDA, members of Congress, and, finally, a letter signed by 1,040 interventional pain physicians to withdraw the FDA warning and a request not to implement regulations emerged. The final version of Rathmell et al’s article which appeared in press is slightly different than the MPW’s press release. The final version published and considered by MPW failed to meet consensus of FDA SUI . In fact, these were considered by MPW which ceased to develop LCDs.PDF