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On April 23, 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 corticosteroids’ drug labels to describe these risks. The FDA recommends 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.”
ASA is extremely concerned that the FDA’s Safety Announcement does not differentiate between the risks and benefits of transforaminal and interlaminar routes of administration, and particulate and non-particulate formulations of steroids. The ASA Committee on Pain Medicine is reviewing the Safety Announcement and its repercussions on the practice of pain medicine, and ASA will communicate these concerns in a formal response to the FDA.
The FDA issued this warning unilaterally and at the same time as the FDA Safe Use Initiative has been working with physician experts from multiple organizations, including ASA, to help create a set of expert recommendations for the safe administration of epidural steroid injections. These recommendations were presented at a special panel during the ANESTHESIOLOGY™ 2013 annual meeting. ASA supports this collaboration, including the diligent efforts of James Rathmell, M.D., Chief of the Division of Pain Medicine at Massachusetts General Hospital and member of ASA’s Committee on Pain Medicine, who is working with the FDA Safe Use Initiative to develop these recommendations and has spearheaded efforts to promote the safe use of epidural steroid injections.
Following the release of the warning, the FDA Safe Use Initiative approached the fourteen societies represented on the Multi-society Pain Workgroup (MPW) to review these recommendations. The societies represented in the MPW include:
1. American Academy of Neurological Surgeons (AANS) *
2. American Academy of Pain Medicine (AAPM)
3. American Academy of Physical Medicine and Rehabilitation (AAPM&R)
4. American College of Radiology (ACR)
5. American Pain Society (APS)
6. American Society of Anesthesiologists (ASA)
7. American Society of Neuroradiology (ASNR)
8. American Society of Regional Anesthesia (ASRA)
9. American Society of Spine Radiology (ASSR)
10. Congress of Neurological Surgeons (CNS) *
11. International Spine Intervention Society (ISIS)
12. North American Neuromodulation Society (NANS)
13. North American Spine Society (NASS)
14. Society of Interventional Radiology (SIR)
* AANS/CNS receive a single vote.
** ASIPP was involved in the MPW upon its inception, but subsequently resigned from participation.
The MPW was originally formed to assist Medicare contractors in developing more consistent local coverage determinations through multi-society consensus recommendations. Each society in the MPW votes on the recommendations, providing for a democratic and transparent process with each society having an equal voice. ASA is committed to working with the other pain medicine specialty societies in the MPW to produce multi-society endorsed recommendations that will help address ongoing concerns with the safe administration of epidural steroid injections.
ASA will continue to update its members on this important patient safety issue.
Read ASA’s April 25, 2014 Washington Alert on the FDA Safety Announcement.
