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.
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