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Ask The Doctor-Fillers off Label?

Article-Ask The Doctor-Fillers off Label?

What does it mean to use Botox or fillers off-label?Dr. Schlessinger:> Just as with any drug, there are drug- specific treatment indications that are submitted to the FDA for approval, and other treatment indications that may be pursued after the drug's approval. Using a drug or device off-label for non-FDA approved indications isn't unusual. For example, any person who has ever been on minocycline for acne might be surprised to learn that when they used this drug, it was used off-label for a non-FDA approved indication. While millions of prescriptions for minocycline have been written, no actual FDA tests have ever been done on that drug for acne. Nonetheless, thousands of papers and informal studies have been performed that show it to be helpful for acne. Drugs such as Botox or fillers (Restylane, Perlane, Juvéderm and others) have been FDA approved for very limited uses, and cosmetic surgeons (dermatologists and plastic/ENT/oral maxillofacial surgeons) have since developed other uses for these products. Although Botox is FDA approved to treat the frown lines between the eyes on the brow only, other areas, such as forehead wrinkles, crow's feet and lip lines, are also commonly treated with Botox. And while just about every area on the face has, at one time or another, been injected with fillers, most fillers are FDA approved for treating the lines around the mouth (nasolabial folds). Off-label injections of Botox and fillers on the other areas of the face are common and, in the right hands (and that is always a huge part of the equation), these injections are safe. If you have any concerns about the use of Botox or fillers for off-label use, be sure to talk to your cosmetic surgeon and make doubly sure you are in the office of someone who has been trained thoroughly, who does his or her own injections and doesn't pass off the injection process to someone else.

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