What Is Off-Label Use? A Doctor Explains

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."


Related Links:
Beyond Wrinkles: 6 Surprising Uses for Botox
Injections or Surgery: When's the Right Time?

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4 Comments
  • Michelle
    Posted on

    I think people don't entirely understand the risks of these products in their entirety - even when used as approved the FDA. For example, Juvederm is FDA approved to be injected into the nasolabial folds; however, that area is very vascular and if the doctor/nurse injecting it puts the product into a vein (obstructs) or even too close (compresses) then the patient could be subject to tissue necrosis. In the hands of a skilled injector fillers and botox are very safe, even when used off label. The key is going to someone who does alot of it and knows which types of products are safe for the different areas of the face. The riskiest fillers are always the longer lasting ones that cannot be reverse with enzymes - if the consumer is truly concerned about safety, the best bet is to stick with only hyaluronic acid fillers that can be reversed if something goes wrong.

  • Samuel M. Lam anonymous
    Posted on

    This is an excellent article and unfortunately this is still a very confusing topic for the public to understand. Unfortunately, this battle can also be a political one in which one doctor says that something is "not approved" for use when what they mean to say is that it is "off label". clearly if something is not FDA cleared for use in the human body, then that is illegal in the United States. I always struggle with trying to inform my patients clearly about matters without obfuscating or confusing them. The best way that I try to explain it is that the FDA typically only clears one indication then the company does not want to spend unnecessary money clearing it for every single indication that is similar to it. The example used is Botox has been cleared for the frown lines but not the smile lines but obviously everyone uses it there. Interestingly, I hear Allergan is working to get FDA clearance there. Why? to be safer? No, because that way they can market it for use there and provide educational seminars and advertisements for that area. Right now, companies can only advertise the specific indications that have been cleared by the FDA whereas physicians may advertise off label indications. Since companies have huge direct to consumer ads, they are increasing their indications even though there may not be another reason to do this other than just placing ads. Another example is Medicis got the indication to perform lip enhancements with Restylane. Was that needed for safety reasons? Absolutely not. It was simply so that they could advertise use of Restylane in the lips in consumer magazines, television, print brochures, etc.

  • Tiffany
    Posted on

    I think what the Dr. is saying is that Off-Label is basically using one product for another purpose. Like Botox, instead of in your crows feet or using it around your mouth to upturn the corners. Not unsafe or cheaper, but an alternate. Your Doc just REALLY needs to know their products and the best and best alternates uses of them. Do your research.

  • melissa
    Posted on

    So when I see something written in an article that says using this product off;-label, thats not dangerous? Sometimes its confusing?

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