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Aging News & Information

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 canthal lines.

 

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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 excessive fluid.

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 www.fda.gov/MedWatch or by calling 800-FDA-1088.

Botox Cosmetic is manufactured by Allergan Inc. based in Irvine, Calif.

For more information:

FDA Approved Drugs: Questions and Answers 

What is Botox?

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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