BOTOX and the FDA: What Do Approvals Mean?

BOTOX and the FDA: What Do Approvals Mean?

Posted 12/14/2017 by Admin

The team at West County Plastic Surgeons of Washington University offers a range of uses for BOTOX® injections. St. Louis-area men and women may have seen that the treatment is FDA approved for smoothing out frown lines between the eyebrows, crow’s feet next the eyes, and—as of October 2017—horizontal forehead lines. But a quick scan of the conditions that local doctors treat with BOTOX® Cosmetic contains more than just those few wrinkles. Why the disparity?

First, a brief explanation of FDA approvals: The U.S. Food and Drug Administration regulates a wide variety of goods and products in the country, working to ensure the good health of the general population. In its role as an overseer, it can give official approvals to medications that have been rigorously tested and put through trials to determine their safety and efficacy. Once a product is approved by the FDA, its manufacturer can market it as having the specifically approved benefits.

This doesn’t mean the product does only what the FDA has approved it to do. Remember, the approval weighs heavily on how a product can be marketed by its maker. Doctors familiar with the product and experienced in its use are free to apply it in other situations, allowing patients to enjoy results that may not yet officially be approved. In some cases, studies involving these uses are ongoing. In other cases, benefits may have only just begun to become apparent as doctors notice them.

With BOTOX®, for instance, its approved cosmetic uses on the forehead stemmed from medical applications to curb ophthalmology-related problems. The administering doctors noticed that their patients not only found relief from their medical symptoms, but also saw a visible reduction in their wrinkles. While these effects were eventually noted by the FDA with an approval, BOTOX® Cosmetic has since gained a long list of other unofficial uses, known as “off label” applications.  

At West County Plastic Surgeons of Washington University, doctors use BOTOX® Cosmetic to smooth out wrinkles on the bridge of the nose (bunny lines), weaken muscles that pull eyebrows downward, relax specific muscles to enhance the look of the lips, and reduce the appearance of neck bands.

Find out more about BOTOX® can do in St Louis at West County Plastic Surgeons of Washington University. Call (314) 996-8800 or send a message online.

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If you have questions or would like to book a consultation with one of the surgeons at West County plastic Surgery, please call (314) 996-8800

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