If you’ve done research online for certain MedSpa or cosmetic procedures, you might have stumbled across the term “off-label.” In the US, prescription drugs require an FDA approval to be prescribed to patients, but these drugs are often prescribed for uses outside of the FDA approval guidelines for that drug—that’s where the term “off-label” comes from. Per WebMD, “Off-label” means the medication is being used in a manner not specified in the FDA’s approved packaging label, or insert.”
Why does the FDA allow off-label use?
After the FDA approves a drug—which is an extensive process where the FDA evaluates the safety, effectiveness, and indication for a drug—healthcare providers can generally prescribe the drug for an “off-label” use if they come to the determination that it is medically appropriate for a particular patient. A practitioner might choose to take such an approach if all other prescriptions have failed or if the patient would benefit from the off-label use, as is the case with many cosmetic and aesthetic procedures.
What cosmetic treatments are considered FDA approved vs. “off-label?”
Botox is FDA approved for the crows feet and glabella area (the area between the eyes) to reduce the appearance of fine lines and wrinkles. However, Botox is often used in the forehead, nose, lip, jaw, chin, and underarm areas, as well, meaning these are “off-label” uses for the prescription.
Likewise, some fillers, such as Juvederm, Voluma, and Restylane, are FDA approved for use in the nasal labial folds, lips, and cheeks, but are also used in the chin, bridge of the nose, and under the eyes.
What do I need to consider if a practitioner uses “off-label” practices?
Many MedSpas and clinics offering cosmetic services will apply treatments and prescriptions for both their FDA-approved and “off-label” uses. Doing so serves the client by offering the benefits of a prescription, such as Botox or fillers, to fully meet the patient’s goals. What you want to be sure of is that you’re working with a reputable provider that knows what they’re doing and has conducted several of the procedures you’ve been prescribed. Read more about selecting a reputable provider by reviewing “What to Look for in a Reputable MedSpa and Cosmetic Services Establishments.”
DermaTouch RN just celebrated their 10 year anniversary and plan to be around for several more decades to come. Contact us today to determine the best approach to meet all of your skin care and cosmetic needs and to better understand “off-label” utilization!