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Matt Hlavacek, MD, DDS
Jason Baker, DDS



Fillers and Botox, what does “off-label” mean, and does it matter?

July 15, 2014, 2:29 am

off-label-botox“FDA-approved” — if you look at advertising for medications, medical devices, and many other health-care related products, this simple phrase shows up quite a lot. With some items, you might even specifically look for this phrase. For example, if you are considering breast augmentation, you should only use FDA-approved implants and never a non-approved or off-label product. However, there are some instances when it might be okay to use products that are “off-label,” particularly when it comes to Botox® and dermal fillers.

What do FDA-approved, off-label, and contraindicated mean?

Before having any type of cosmetic procedure done, it is important that you, as a consumer, understand the terms FDA-approved, off-label, and contraindicated. Your safety may depend on it.

FDA-approved: FDA-approved means that the Food and Drug Administration has reviewed the results from all manufacturer testing done on a product, medication, or treatment, and has granted approval for its use for a specific purpose. Approval by the FDA indicates that the product, medication, or treatment has been deemed safe enough that the benefits are greater than the potential risks when considering the intended use.

Off-label: Off-label use indicates that an FDA-approved product is being used for a purpose other than its original intended purpose based on a thorough evaluation of the patient’s needs. Off-label use isn’t generally advertised as it indicates use that has not received FDA-approval but is generally considered safe.

Contraindicated: Contraindicated means that the product, medication, or treatment should not be used in particular ways. Absolute contraindications are when there are known likelihoods of adverse effects and the item should never be used in a certain manner or for a certain population. Relative contraindication means that there is high potential for an adverse effect, and the procedure, treatment, or medication, should only be performed in certain situations if absolutely necessary.

What does off-label use have to do with Botox® and dermal fillers?

Off-label use with dermal fillers and Botox® is actually fairly common. Although Botox® is FDA-approved to treat vertical lines between the eyebrows, it is common for cosmetic surgeons to also use it to treat crow’s feet or certain other wrinkles and lines in the face, if it is deemed warranted after a thorough examination of the patient’s skin. When it comes to fillers, most are FDA-approved for the nasolabial folds or lips, but off-label use might include the cheeks or other areas of the face, again, after a thorough examination of the patient’s skin and face.

It is important to understand that just because Botox® and fillers can be used in off-label ways, doing so many not always be appropriate. At Kansas City Surgical Arts, Dr. Hlavacek will discuss your goals with you and examine your skin and face before determining the best use of fillers or Botox®. Depending on your goals and his evaluation, you may be a great candidate for the FDA-approved uses of Botox® or fillers, or you may be a candidate for off-label use. Contraindicated uses of these products simply aren’t an option, as your health and safety are our first priority.

Avoid complications with Botox® and fillers

For a brief period when Botox® first became available, it was fashionable to have Botox® parties; however, patients who went to these parties, often at a private residence or an upscale hotel suite, put themselves at risk for a number of complications. It is crucial that the person administering your Botox® or dermal filler is a highly-trained professional and administers your treatment in a clinical setting.

In addition to only seeking treatments from a trained professional in a medical setting, it is important to communicate your goals clearly to your injector. If your goals are best treated through off-label use of Botox® or fillers, you should be informed, and if off-label use makes you uncomfortable, despite its record of safety in most instances, you have a right to refuse the treatment or ask about alternatives.

Botox® and dermal fillers are considered contraindicated by the FDA for pregnant or breastfeeding women. You are best advised to wait until you are no longer pregnant and not breastfeeding to seek these treatments.

Ready to learn more?

To learn more about how Botox® or dermal fillers may benefit you, call Kansas City Surgical Arts today at (816) 286-4126 to schedule a complimentary cosmetic consultation with Dr. Hlavacek. He will evaluate your goals and the condition of your skin and face and help you determine which type of treatment is best for your needs. Kansas City Surgical Arts offers Botox® Cosmetic, Dysport®, Juvederm®, and Radiesse®.