fda approves botox cosmetic for the forehead 5f6220450e5e8

FDA Approves Botox Cosmetic for the Forehead

Las Vegas Plastic Surgery


From Allergan: “Today Allergan plc (NYSE:AGN) announced the FDA approval of BOTOX® Cosmetic for its third indication, the temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis muscle activity in adults. This approval makes the brand the first and only neurotoxin indicated for three facial treatment areas – forehead lines, crow’s feet lines and glabellar lines (1). As the category leader, BOTOX® Cosmetic is also the only neurotoxin brand to receive approval of aesthetic indications beyond glabellar lines in the U.S.”

Many experienced injectors have used Botox “off label”, (meaning, it did not have an FDA approved indication for this area), into this forehead for quite a while. The anatomy and physiology were well known, and many have found this treatment to be safe and effective.

There are a couple of interesting points about this particular injection site that should be pointed out. Like any procedure, a good history and physical can help identify potential issues. In this particular case, some patients have extra skin on their upper eyelids. Sometimes these patients will use their forehead muscle, (the frontalis muscle), to raise the eyebrow, and the upper eyelid. Often, patients do not know consciously that they are doing this. If this patient has their frontalis muscle completely “frozen,” the eyebrow may move downward and the upper eyelid skin can appear worse. It is important to see an experienced injector who is knowledgeable in this area.

Botox can be very safe, and effective. Again, from Allergan, “Approved for use in over 75 countries, BOTOX® Cosmetic is the most widely researched and studied treatment of its kind (2). The safety and efficacy have been evaluated in Allergan clinical studies and described in nearly 500 peer-reviewed articles in scientific and medical journals (3, 4). BOTOX® Cosmetic is manufactured in a state-of-the art facility under strict quality and safety standards.”

Like any other medicine, one needs to know the risks and benefits, and then use the best judgment for the best outcome for their patient.

Please call with any questions.

Jeffrey J. Roth, M.D., F.A.C.S.
Las Vegas Plastic Surgery

1. BOTOX® Cosmetic Prescribing Information 2017.
2. BOTOX® Cosmetic Website, (https://www.botoxcosmetic.com/…) 
3. Data On File Allergan, Inc.; Peer-Reviewed Articles, 2015.
4. Data On File Allergan, Inc.; Patient Clinicals, 2015.

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