What Is Off-Label Use? A Doctor Explains
By Shellie Terry Benson |
Nearly every day we hear stories about the FDA clearing or approving certain products and medications for particular uses, however, some physicians choose to use products like neurotoxins (Botox, Dysport or Xeomin) and dermal fillers "off-label," which may cause some patients to wonder: What is off-label use and is it safe? We turned to Eugene, OR, plastic surgeon Mark L. Jewell, MD, who actually wrote the book for the Physicians Coalition for Injectable Safety: The Safety With Injectables Workbook.
"Off-label use is legitimate," Dr. Jewell says. "But it's something a doctor discusses with the patient to meet the patient's specific needs. It's not proper to advertise off-label use. It has to be something that's developed after a doctor-patient evaluation."
Neurotoxins are FDA approved for treating the vertical frown lines between the eyebrows. After evaluating the patient, a doctor may choose to use the neurotoxin to treat crow's-feet, neck bands or down-turned corners of the mouth, all of which would be considered off-label, Dr. Jewell explains.
Fillers, which are FDA approved to improve the look of nasolabial folds or the lips, might be used off-label to increase fullness in the cheeks. But the physician's experience and expertise with these products should be the determining factors in how he or she uses them. "Sometimes it makes good sense to use a filler or a neurotoxin in an off-label fashion. Sometimes it doesn't," Dr. Jewell says. "Some fillers like Sculptra or Radiesse shouldn't be used in lips or tear trough area because they don't work that well and can cause adverse events."
As a physician, "you need to understand what the patient wants and see if you can deliver it with your skill set as an injector and the products you have," Dr. Jewell says. "You need to find a filler or toxin you're comfortable with in terms of effectiveness and safety profile. And keep records and document your strategy plan," which he outlines in the injectables safety workbook.
"Off-label use is a common practice," Dr. Jewell says. "And there's nothing inappropriate about a patient asking a doctor about his experience in using something off-label."
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