FDA-Approved Label vs. Off-Label: What Does It Mean?

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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!

Top Five Cosmetic Procedures to Lift and Brighten Your Holiday Season

As the holidays approach and party plans start to take shape, both men and women are scheduling cosmetic procedures to ensure everyone looks their holiday best.  Gift certificates are also proving popular stocking stuffers.

Among the top five pre-holiday procedures individuals seek include:

Simple cosmetic procedures can transform for the holidays.

Simple cosmetic procedures can transform your holidays.

 

Injectables and Fillers

While among the most popular cosmetic procedures year-round, injectables such as Botox and DySport and fillers such as Juvederm, Restylane, Voluma, Sculptra and the latest in injectable treatments, Kybella, top the list in requested cosmetic procedures in preparation for the holidays.  These simple procedures take little time to perform in the office and produce immediate results – eliminating furroughed brow and forehead lines, reducing the appearance of crows feet, smile and lip lines, as well as lifting brows and subtly plumping lips.

Skin Rejuvenation

Enhanced skin rejuvenation laser therapy helps shed the visible wear of the past year, reinvigorating sun-damaged skin and reducing visibility of age spots, lentigines and facial telangiectasia. Patients with photo-damage and photo-aging often benefit from this type of procedure.

Skin Rejuvenation Laser Therapy Specifically Addresses:

  • Sun damage
  • Wrinkles
  • Photo-aging
  • Lentigines and facial telangiectasia
  • Vascular and pigment irregularities

“Painting” the entire face with the laser, patients typically see clearing of sun damage, wrinkle improvement as collagen forms and overall younger looking skin.  Optimal benefit may require three to eight treatments.

Laser Hair Removal

Hair removal procedures are very popular in preparation for skin baring holiday styles. Utilizing the latest in laser hair removal technology, registered nurses safely remove hair by heating the area at the base of the hair shaft, permanently preventing hair regrowth.

The laser procedure targets the pigment in the hair follicle, which works on either black or brown hair, and must be performed during a specific phase in the hair’s growth cycle (active or anagen phase).  Multiple treatments are required and vary with each individual and by body site.

Skin Tightening with SkinTyte

Skin tightening treatments are among the fastest growing laser procedures in the aesthetic industry. Using infrared energy, SkinTyte is safe for all skin types and can treat any area of the body (face, neck, arms, abdomen, knees), giving skin a firmer and more youthful appearance. There is no need for topical anesthetic, no down time, and no excessive redness. This is truly a lunchtime procedure!

Laser Vein Therapy 

A beautiful pair of legs can greatly enhance a holiday dress.  With a revolutionary new laser vein therapy treatment,  spider veins and other distracting veins are quickly and safely eliminated.  Vein removal treatment, including Sclerotherapy and Alscera, effectively eliminates broken capillaries up to 4 mm in diameter on the face and legs as well. Utilizing advanced technology redness and bruising associated with traditional treatments are minimized. This laser vein therapy technology also allows treatment for people of any ethnic origin and skin type, including tanned skin.

Check out weekly and monthly DermaTouch RN specials and schedule an appointment before your next holiday party!