The FDA 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, manufactured by Allergan Inc. based in Irvine, California, 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. Botox Cosmetic is administered via intramuscular injections. Treatment for both frown lines and crow’s feet can be given at the same time.
“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.
OnabotulinumtoxinA is marketed as Botox and Botox Cosmetic. The FDA previously 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. 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.
See the FDA Announcement
See also Medical Law Perspectives, September 2012 Report: Cosmetic Surgery Gone Wrong: High Hopes Meet Unexpected Results
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication