FDA одобрила применение Ботокса для коррекции «гусиных лапок» (на англ. языке)

28.10.2013

The US Food and Drug Administration (FDA) has approved use of onabotulinumtoxinA (Botox Cosmetic, Allergan) for temporary improvement in the appearance of moderate to severe lateral canthal lines, also known as crow's feet, in adults.

Botox Cosmetic is currently the only FDA-approved drug treatment option for lateral canthal lines, the FDA said today.

The agency approved Botox Cosmetic in 2002 for the temporary improvement of glabellar lines (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," Susan Walker, MD, director of the Division of Dermatology and Dental Products in the FDA's Center for Drug Evaluation and Research, said in a statement.

Botox Cosmetic is administered via intramuscular injections. Treatment for both frown lines and crow's feet can be given at the same time, the FDA said.

Boxed Warnings

The approval of Botox Cosmetic for treating lateral canthal lines was based on 2 clinical efficacy and safety studies involving 833 adults with moderate to severe lateral canthal lines who were randomly assigned to receive either Botox Cosmetic or placebo.

The results showed that those treated with Botox Cosmetic had greater improvement compared with placebo in the appearance of lateral canthal lines, the FDA said.

Eyelid edema is the most common adverse reaction associated with the use of Botox Cosmetic for treatment of lateral canthal lines, the agency said.

Botox is also approved for the treatment of chronic migraine, as reported by Medscape Medical News, as well as severe underarm sweating, blepharospasm, and strabismus.

Botox and Botox Cosmetic have a boxed warning saying 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, the FDA said.

Healthcare professionals are encouraged to report adverse reactions from the use of Botox Cosmetic to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787


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