News Release (FDA)
September 11, 2013
The U.S. Food and Drug Administration today approved a new use for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of moderate to severe lateral canthal lines, known as crow's feet, in adults. Botox Cosmetic is the only FDA approved drug treatment option for lateral canthal lines.
The FDA approved Botox Cosmetic in 2002 for the temporary improvement of glabellar lines (wrinkles between the eyebrows, known as frown lines), in adults. Botox Cosmetic 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.
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.
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