Safety Concerns About BOTOX

A common question we receive from our clients has to do with the safety of BOTOX injections.  Many of our patients know that the BOTOX serum used in wrinkle treatment is derived from a bacteria that can cause food poisoning.  How can a patient be comfortable that the active ingredient in BOTIX will not cause any damaging effects?

BOTOX® cosmetic (Botulinum Toxin Type A) is produced and sold in the United States by the pharmaceutical manufacturer Allergan.  Similar formulations are produced by other drug companies in Europe and Asia.  BOTOX was first approved by the FDA in 1989 for the treatment of uncontrolled eyelid twitching, a condition called blepharospasm.   In December, 2000, BOTOX was approved by the FDA for the cosmetic treatment of the vertical lines between the brows.  BOTOX is also used to treat excessive underarm sweating and some muscle pain disorders.  Many millions of cosmetic patients have been treated globally and Allergan reports that more than 13 million doses have been given since 2002.

Bad reactions to cosmetic uses for BOTOX have been extremely unusual.  To date, there has not been a single death associated with BOTOX, nor has there been any report of any allegies to the serum.

There have been some adverse reactions to BOTOX when it has been used to treat various neuromuscular diseases.  In these treatments, BOTOX doses up to 100 times greater than cosmetic doses were given to children with neuromuscular diseases.  The manufacturer notes that this use of BOTOX in individuals with neuromuscular disease is not FDA approved and is an entirely different application than the cosmetic use of BOTOX.

BOTOX does not function as a permanent solution to wrinkles - most treatments will last three to eight months.  BOTOX remains the most popular cosmetic procedure in the United States and it has proven to be both safe and effective.