Epidural steroid injections (ESIs) are commonly used to treat the radicular pain associated with many spinal disorders.
Although ESIs have proved to be effective in managing this type of pain, neurologic complications including stroke and spinal cord injury have occurred infrequently.1
“There have been rare but serious neurological adverse events – including loss of vision, stroke, and paralysis – which have infrequently resulted in death,” said Kristofer Baumgartner, U.S. Food and Drug Administration (FDA) spokesperson.
According to James P. Rathmell, MD, executive vice chair and chief of the division of pain medicine at Massachusetts General Hospital in Boston, Massachusetts, neurologic injury ranges from individuals with severe sciatica associated with a new lumbar disc herniation to those with more chronic and recurrent pain.
“They all have in common a relatively simple procedure done with little difficulty. But soon after the steroid is injected, new neurologic deficits appear, ranging from isolated pain in an extremity to profound numbness and weakness in both extremities,” said Rathmell.
FDA Safe Use Initiative and Working Group
In an effort to reduce or eliminate these neurologic complications and provide clinical practitioners with recommendations for using these injections more safely, the FDA Safe Use Initiative formed a collaboration with multiple specialty societies.
The FDA’s Safe Use Initiative provided the panel of experts with a forum for their discussions about the safety and effectiveness of ESIs as well as the practices that potentially can minimize the associated risk. However, the FDA did not actively participate in the deliberations or the decision-making process.
“The ultimate goal of the panel of experts and representatives of the participating national pain organizations is to minimize the risk of ESI-related neurologic injuries, to the extent these injuries are related to clinical administration procedures and techniques. With this goal in mind, the panel of experts and representatives of the national pain organizations agreed on the breadth, content, and specificity of the clinical considerations, and they have published the clinical considerations for health care professionals who administer ESIs as a treatment for neck and back pain,” said Baumgartner.
The working group reviewed the existing evidence on neurologic complications tied to ESI and provided recommendations for improving safe use of these injections. “The Safe Use Initiative was formed well before they collaborated on this project. The concept is to team up with medical experts to assemble information that improves the safe use of medications and devices that cannot be well addressed through the FDA’s usual regulatory functions. In this case, epidural injection of corticosteroids is an off-label use of this medication, thus the regulatory limb of the FDA has no direct role,” said Rathmell.