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Who Decides What BOTOX® is For?

Who Decides What BOTOX® is For?

In October 2017, the U.S. Food and Drug Administration gave its third-ever approval to BOTOX® Cosmetic, officially recognizing it as an option for patients who want to smooth out their horizontal forehead lines. Whereas the injectable was previously approved for frown lines between the eyebrows and crow’s feet radiating from the corner of the eyes, those were not the only conditions that could be treated with BOTOX injections. San Francisco-based Dr. Stanley Jacobs, for instance, has long used the neuromodulator to address a range of other issues, including perennially lowered eyebrows, bunny lines on the nose, a downturned mouth, unwanted chin dimpling, and visible neck bands.

If the prescription cosmetic can do so much, why does the FDA say it’s only good for three uses?

The Food and Drug Administration bases its approvals on successful studies and trials conducted to explore specific applications. If research demonstrates that a particular use safely yields consistent and predictable results, the FDA will give that use a nod—which means the manufacturer can officially market the product as generating a specific effect for a known duration. Without the approval, no such marketing claims can be made.

The studies leading to an FDA approval often stem from the fact that doctors frequently develop applications for products beyond what they were initially created to do. In the case of BOTOX®, what started as a solution to eye-muscle problems and eyelid spasms became an underground boon to medical patients who also noticed their foreheads getting smoother.

While FDA approvals certainly provide an added layer of accountability and can impact patient perception of a drug, experienced doctors are often at the forefront of revolutionary new applications—called “off label” uses when they haven’t yet been recognized by the FDA.

As long as a patient is aware of the nature of the treatment and trusts the doctor to be making sound choices, off-label uses of BOTOX®—and other treatments—often represent a vital avenue for men and women seeking the most effective ways to present a fresh, rejuvenated look to the world.

Learn more about the many uses of BOTOX® Cosmetic by calling The Jacobs Center for Cosmetic Surgery in Healdsburg at (707) 473-0220 or visit the Contact Us page.

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