FDA approves Botox Cosmetic® to improve the appearance of crow’s feet lines
After years of widespread “off label” use by Dr. Steve Laverson and thousands of physicians, surgeons, nurses, and patients, the powerful United States Federal Government Food and Drug Agency formally approved the use of Botox Cosmetic® to soften dynamic creases at the sides of the eyelids that develop during adult aging. Known as lateral canthal lines or “crow’s feet,” Botox®(onabotulinum toxin A) and other neuromodulators such as Dysport® (abobotulinum toxin A) and Xeomin® (incobotulinum toxin A) have a long track record of safety and success for temporary improvement in the appearance of moderate to severe lateral canthal lines.
The Food & Drug Administration (FDA) approved Botox Cosmetic® in 2002 for reduction of wrinkles between the eyebrows, known as “squint,” or frown lines. Botox Cosmetic® (Onabotulinum toxin A) prevents muscle contraction for several months. By relaxing muscles that express anger, concern, and worry, wrinkling of skin on top of these muscles is prevented. Use of botulinum toxin neuromodulators repeatedly over years prevents features of facial aging and maintains smooth, youthful skin. Additionally, the botulinum toxins have proven to be effective prevention for certain types of headaches such as migraine.
“This added approval offers the public a new FDA approved treatment for adults desiring reduction of crow’s feet wrinkles at the sides of the eyes,” said Susan Walker, M.D., director of the Division of Dermatology and Dental Products in the FDA’s Center for Drug Evaluation and Research.
Botox Cosmetic® is delivered into the site of activity via injection into the orbicularis oculi muscles which lie directly beneath crow’s feet wrinkles. The muscles are “sphincter” type with fibers passing perpendicular to the direction of creases. Treatment for frown lines and crow’s feet have been offered simultaneously for over a decade by Dr. Steve Laverson and other plastic surgeons and cosmetic specialists.
The FDA examined findings of two studies using Botox Cosmetic® to diminish lateral canthal lines. 833 adults with lateral canthal lines were randomly assigned to receive Botox® or placebo. Those treated with Botox® had significantly improved resolution of crow’s feet lines compared to the placebo treatment group.
There were no major complications or adverse effects associated with the use of Botox Cosmetic®. Temporary eyelid edema (swelling) resulted from treatment in both the Botox® and the placebo group, but this was considered a mild adverse effect, and was self limiting in all cases.
The FDA previously approved Botox® for the treatment of chronic migraine, severe underarm sweating (hyperhidrosis), blepharospasm (involuntary eyelid spasm) and strabismus (misalignment of the eyes when one or both eyes turn inward or outward). Botox® and Botox Cosmetic® have a warning packaged with each vial about unintended spread from the area of injection to other muscles, causing symptoms similar to those of botulism. Those symptoms include swallowing and breathing difficulties that can be life-threatening. In worldwide use however, there has never been a serious case of botulinum toxin spread resulting from the use of Botox® or Botox Cosmetic® by skilled operators for approved indications.
Patients and physicians are advised to report adverse events related to the use of Botox Cosmetic® to the FDA’s MedWatch Reporting program at www.fda.gov/MedWatch or by calling 800-FDA-1088.
Botox Cosmetic is manufactured by Allergan Inc. with corporate headquarters in Irvine, CA. Steve Laverson, MD is a board certified plastic surgeon in Encinitas, CA with extensive experience using neuromodulators for multiple applications.