Outpatient Surgery Magazine

Thumbs Up on Safety Scalpels - May 2019 - Subscribe to Outpatient Surgery Magazine

Outpatient Surgery Magazine, providing current information on Surgical Services, Surgical Facility Administration, Outpatient Surgery News and Trends, OR Excellence and more.

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Page 28 of 112

practice of medicine and not regulated by FDA." The courts, as this month's case shows, took a sterner view. In 2013, a 60-year-old Colorado woman underwent ESI at The Surgery Center at Lone Tree (osmag.net/YoHAn4) with Kenalog (tri- amcinolone acetonide), which the FDA warned cannot be used for epidural injection. The patient received 4 injections of the glucocorti- coid on the right side of vertebrae L1 and L2, court records show. Soon after the final Kenalog injection, in the recovery area, the patient lost motor function and complete sensation from the waist down. She and her husband sued the surgery center, and were awarded $14.9 million. She remains a paraplegic. The side effects of Kenalog are rare and typically minimal when properly administered, but the risks are significantly greater when injected into the spine. Two years before the woman received the injection, Bristol-Myers Squibb, aware that Kenalog could cause spinal cord injury during ESI, petitioned the FDA for permission to modify Kenalog's warning label to read "Not for Epidural Use." In part, the warning now reads: "Spinal cord infarction, paraplegia, quadriplegia, cortical blindness and stroke (including brainstem) have been report- ed after epidural administration of corticosteroids." Not only did the FDA and the manufacturer note its dangers, but many peer-reviewed articles have debated the safety of Kenalog for ESI. Physicians who order medications or treatments for patients have the absolute responsibility to know the risks, benefits and alterna- tives, as well as warnings and contraindications. As part of informed consent, it's the physician's responsibility to properly discuss those same risks, benefits and alternatives with the patient. Only when a patient is properly informed of those facts can she give — or withhold — her consent. M A Y 2 0 1 9 • O U T PA T I E N T S U R G E R Y. N E T • 2 9

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