Botulinum toxin A or ‘Botox‘, has already earned quite a reputation for erasing wrinkles and facial rejuvenation to make skin appear fresh and youthful. Now, the drug has got the green signal from health regulators to treat crow’s feet, the wrinkles around the corner of the eyes.
Allergan Inc. has won Food and Drug Administration’s (FDA) official approval for its anti-wrinkle injection Botox to treat ugly crow’s feet wrinkles.
While the new federal approval for Botox came on September1, doctors have been doing the procedure “off the book” for years to smooth the crow’s feet’.
Crow’s feet are believed to be produced by repeated muscle contractions through facial expressions like frowning, smiling and squinting.
“This additional indication will provide people with a new FDA approved treatment option for those seeking a smoother appearance by temporarily minimising the appearance of crow’s feet at the sides of the eyes,” said Susan Walker, director of the Division of Dermatology and Dental Products in the FDA’s Center for Drug Evaluation and Research.
Safety and efficacy assessed
The federal approval came after the safety and efficacy of Botox as a treatment for crow’s feet was assessed in two randomized, multi-center, placebo-controlled clinical trials by the company.
For the purpose of the study, 833 adults were randomly given either a Botox or a dummy injection. Botox Cosmetic is administered by intramuscular injection. The treatment for frown lines (officially known as glabellar lines) and crow’s feet (lateral canthal lines) is also given at the same time.
The trial found people injected with Botox displayed a greater reduction in crow’s feet and enhancement in looks compared to the control group, which receive the sham treatment. The impact of the Botox cosmetic treatment lasted for nearly four to six months. The only adverse effect was eyelid edema, which caused the eyelids to swell due to fluid buildup.
Scott Whitcup, executive vice president, Research and Development, chief scientific officer, Allergan stated, “We are pleased that the FDA has approved a new indication for Botox Cosmetic to temporarily improve the appearance of crow’s feet lines. With this approval, Botox Cosmetic is now the only pharmaceutical approved to treat both crow’s feet lines and frown lines between brows. This approval will enhance our ability to work with and train aesthetic physicians on the science of administering Botox Cosmetic to yield the best possible outcomes for patients.”
Botox contains box warning
Botox (botulinum toxin type A) is a neurotoxin protein produced by the bacterium Clostridium Botulinum. It is one of the most poisonous naturally occurring substances hence experts use it in very small amounts to stop muscle spasms.
Botox carries a strong warning indicating that the effects of the drug may spread from the injection site to other parts of the body, causing life-threatening symptoms including swallowing and breathing difficulties. However, no incidents of such migration have surfaced where Botox was used at recommended doses.