On November 7, 2014, the American Society of Anesthesiologists (ASA), American Society of Regional Anesthesia and Pain Medicine, American Academy of Pain Medicine, and International Spine Intervention Society sent a formal letter to the U.S. Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee in response to their upcoming November 24-25 meeting on the safety and effectiveness of epidural steroid injections.
According to the FDA, “The committee will discuss the risk of serious neurologic adverse reactions associated with epidural steroid injections (ESI) administered to reduce inflammation for pain management. The committee will also consider the efficacy of ESI and the overall risk benefit balance of injecting steroids in the epidural space to treat pain.”
This Advisory Committee meeting follows an April 23, 2014 FDA Drug Safety Communication 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 stated that is requiring the addition of a Warning to injectable corticosteroids’ drug labels to describe these risks and 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.”
In regards to the FDA Warning, the multi-society letter to the Advisory Committee states:
We are extremely concerned that the FDA Warning fails to differentiate between the risks and benefits of transforaminal and interlaminar routes of administration, and particulate and non-particulate formulations of steroids. The resulting message inaccurately groups all epidural steroid injections into one broad warning, but the critical distinctions between the routes of administration and formulations of steroids represent the difference between safe and effective use of epidural steroid injections and unsafe use associated with catastrophic injuries. We strongly recommend that the Warning be retracted and replaced with one that accurately represents the risks associated with epidural steroid injections used to manage painful spinal conditions.
ASA also joined a letter submitted by the American Academy of Pain Medicine, and a letter from fourteen pain specialty societies that was submitted by the International Spine Intervention Society, to the Advisory Committee emphasizing these concerns. In addition to these comment letters, ASA will provide formal oral comments at the Advisory Committee meeting in which the Society will express significant concerns with the FDA Warning and discuss the efficacy of ESI.
ASA will continue to work with the FDA and pain medicine specialty societies to discuss the benefits of ESI and to reduce preventable harm.
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