FDA Gives OK to Using Botox to Improve Looks of
Crow’s Feet Common with Aging
Many seniors have used Botox since 2002 when it was
okayed to erase frown lines
Sept.12, 2013 – Yesterday, the Food and Drug
Administration approved Botox for a use that has probably been in use
for years – improving the looks of crow’s feet. It had been approved in
2002 for the “temporary” improvement of wrinkles between the eyebrows,
as frown lines and now becomes the only drug treatment approved for the
moderate to severe lateral canthal lines at the corners of the eyes.
Botox Cosmetic (onabotulinumtoxinA) works by
keeping muscles from tightening so wrinkles are less prominent.
“This additional indication will provide people
with a new FDA approved treatment option for those seeking a smoother
appearance by temporarily minimizing the appearance of crow’s feet 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 administered via intramuscular
injections. Treatment for both frown lines and crow’s feet can be given
at the same time.
Botox Cosmetic’s safety and effectiveness for
treating lateral canthal lines were established in two clinical efficacy
and safety studies. The studies enrolled 833 adult participants with
moderate to severe lateral canthal lines who were randomly assigned to
receive Botox or placebo. Results showed that those treated with Botox
had greater improvement compared to placebo in the appearance of lateral
The most common adverse reaction associated with
the use of Botox Cosmetic for treatment of lateral canthal lines is
eyelid edema, a condition in which the eyelids are swollen and contain
OnabotulinumtoxinA is marketed as Botox and Botox
Cosmetic. The FDA approved Botox for the treatment of chronic migraine,
severe underarm sweating, blepharospasm (eyelid spasm) and strabismus
(misalignment of the eyes when one or both eyes turn inward or outward).
Botox and Botox Cosmetic have a boxed warning that
says the effects of the botulinum toxin may spread from the area of
injection to other areas of the body, causing symptoms similar to those
of botulism. Those symptoms include swallowing and breathing
difficulties that can be life-threatening. There has not been a
confirmed serious case of toxin spread when Botox or Botox Cosmetic has
been used at the recommended dose for the approved indications.
Consumers and health care professionals are
encouraged to report adverse reactions from the use of Botox Cosmetic to
the FDA’s MedWatch Adverse Event Reporting program at
by calling 800-FDA-1088.
Botox Cosmetic is manufactured by Allergan Inc.
based in Irvine, Calif.
FDA, an agency within the U.S. Department of Health
and Human Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines and
other biological products for human use, and medical devices. The agency
also is responsible for the safety and security of our nation’s food
supply, cosmetics, dietary supplements, products that give off
electronic radiation, and for regulating tobacco products.
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