Is BOTOX cosmetic Safe?

The popularity of BOTOX® for the use in cosmetic facial wrinkle treatment, known as BOTOX® cosmetic, is due to its simplicity and tremendous effectiveness. It has become so familiar by popular culture and media communications that its name is often used as both a noun and a verb. (which is both disturbing and discouraged by the manufacturer) Recent negative publicity with its use in children with neuromuscular disorders has not accurately represented its safety record in cosmetic applications. To allay potential patient concerns, it is useful to review some of the factual information about this drug to clear up any confusion created by these recent media reports.

BOTOX® cosmetic (Botulinum Toxin Type A) is produced and sold by the proprietary company, Allergan, based in Irvine California. It has been 18 years since it was initially approved for the treatment of blepharospasm (excessive eyelid twitching) and 6 years since its approval for the cosmetic treatment of the vertical lines between the brows. While accurate numbers are impossible to know, tens of millions of cosmetic patients have been treated around the world with the manufacturer reporting more than 13 million doses given since 2002. According to the American Society of Plastic Surgery, BOTOX® cosmetic is the #1 cosmetic procedure done in the U.S. since 2002 with over 3 million doses given in 2006. These large patient numbers, combined with thousands of patients enrolled in various studies and over 3,000 published medical articles on the subject, provide a wealth of safety information. Despite the large amount of doses administered and patients treated, significant adverse reactions to the use of BOTOX® cosmetic is extremely rare.Any true allergies to its use have not been reported. To date, there has never been a single reported death associated with its use either.

These cosmetic experiences must be contrasted with the media reports where its use has been in limb spasticity, which is not an FDA-approved application. In these neuromuscular uses, substantially larger doses (up to 100 times) are given compared to what is given in cosmetic doses and are injected in patients who are often ill and weakened from their disease. These two patient populations, and their indications, are simply not the same. The FDA appears to recognize these differences and has issued no stoppage of its use for any application to any health care provider at the present time.

The accurate portrayal of the safety data on BOTOX® cosmetic should provide great comfort to those patients who regularly receive aesthetic treatments or to those considering it in the near future.