Editor's Memo: The Conundrum of Epidural Corticosteroid Injections
On April 23, 2014 the U.S. Food and Drug Administration (FDA) issued a safety announcement warning that “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.” As a result, the FDA is requiring the addition of a warning to injectable corticosteroid drug labels to describe these risks. In a press statement, the FDA recommended that “patients should discuss the benefits and risks of epidural corticosteroid injections with their health care professionals along with the benefits and risks associated with other possible treatments.”1
As this memo is being written, several physician advisory and professional groups are attempting to craft guidelines and defenses for epidural corticosteroid injections. Regardless of their efforts, the risk is clear, albeit small, so this issue will alter pain practice going forward.
Three points are abundantly clear: thousands of patients have safely received and clinically benefitted from epidural corticosteroid injections; serious complications, even when the injection is competently done, can occur; and the procedure has sometimes been carelessly performed, and some patients have apparently been victims of overuse of the procedure.
Complications: Infection Control
The complications, to some extent, stem from the early belief that epidural corticosteroid injections were little more than a fancy trigger point injection. The need for immaculate infection control during the procedure was usually not considered to be necessary. This belief has proved false. For example, there are documented cases in which physicians did not wear a mask during the procedure or used single-dose drug vials on multiple patients—leading to infection.2 On top of the risk of bacterial infections, there were the recent reports of spinal and central nervous system fungal infections caused by contaminated, compounded corticosteroid solutions.3,4
Understandably, injured patients and their families have begun petitioning and lobbying FDA and politicians to ban the use of epidural corticosteroid injections. Malpractice suits against interventional pain practitioners are now being filed throughout the United States. One of the major legal claims is that the use of corticosteroids by the epidural route is “off-label.” A key point is that some injured patients, families, and activist groups want a complete end to epidural corticosteroid injections and not a compromise or “promise to do better.”
Over Use of ESI?
Interventional physician groups who wish to defend and administer epidural corticosteroid injections need to understand that the issue is not just about infection control, particulate or non-particulate solutions, or whether the injection is done under fluoroscopic guidance or by the transforaminal or interlaminal routes. For example, one of the great claims I frequently hear is that patients can’t get an opioid prescription unless they first submit to an epidural injection. If this unethical practice exists, it must simply stop. I recently was referred 2 patients who said they had undergone more than 50 epidural procedures. How many epidurals can a patient have without sustaining some damage? It’s quite clear that an injection in and around the dural lining of the spinal cord is a risk, so how many can a patient safely endure?
Another unacceptable common practice today is that epidural corticosteroid injections have become a first line or singular back pain treatment in some communities. Due to the risk of epidural corticosteroid injections, they should only be attempted after conservative, non-invasive treatments have been tried and failed. Furthermore, any risky procedure, such as an epidural injection, should be part on an ongoing, multi-faceted back or neck pain treatment program. Even referring physicians need to be aware that epidural corticosteroid injections are not usually a curative treatment but an exercise to relieve symptoms.
It is my fear that epidural corticosteroid injections will be lost to us as insurance companies and other third party payors deem them too risky to fund. Patients and practitioners have seen the news, are informed, and some are already shying away from recommending or submitting to the procedure. Can we save epidural corticosteroid injections? It will likely take a very candid and open discussion between all parties concerned about the risks, benefits, and indications of this treatment modality. Also, the hysteria and finger pointing over this issue needs to calm down. Too much is at stake.