September 12, 2013
FDA Approves Botox Anti-Wrinkle Treatments For Crow’s Feet
Lee Rannals for redOrbit.com - Your Universe Online
Botox Cosmetic is an injected drug that was approved over a decade ago to treat frown lines, but plastic surgeons have been using it for a wide variety of other cosmetic purposes. And now, a US Food and Drug Administration ruling will allow the anti-wrinkling drug to be used for treating crow's feet.
“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, MD, director of the Division of Dermatology and Dental Products in the FDA’s Center for Drug Evaluation and Research.
The FDA said it enrolled 833 adult participants with moderate to severe lateral canthal lines who were randomly assigned to receive Botox or a placebo. The agency found that those treated with Botox "had greater improvement compared to placebo in the appearance of lateral canthal lines."
Botox has also been approved for treatment of chronic migraine, severe underarm sweating, blepharospasm and strabismus. But most doctors haven't waited for the FDA approval to go ahead and start treating their patients' crow's feet with Botox injections.
A study in 2010 showed that individuals who have been injected with Botox for facial wrinkles experience an increased quality of life and self-esteem. Researchers found that individuals treated with Botox reported an elevation in mood, claiming to be happier.
“The findings in this study ask us to think much differently about Cosmetic Botox treatments,” lead investigator Steven H. Dayan, MD, FACS, Chicago Center for Facial Plastic Surgery, said in a statement at that time. “We have long known the physically enhancing benefits of Botox treatments, but to now have data that indicates Botox also improves one psyche, self-esteem and quality of life is very significant."
The FDA said the most common adverse reaction associated with Botox use is eyelid edema, which is a condition in which eyelids are swollen and contain excessive fluid. Botox contains a boxed warning that says the effects of the botulinum toxin could spread to other areas of the body, which may cause swallowing and breathing difficulties. However, the FDA said there has not been a confirmed serious case of toxin spread when the drug has been used at the recommended dose.