The Food and Drug Administration recently announced that all manufacturers of botulinum toxin, best known for the brand Botox, that there is a risk of paralysis-like symptoms from the distant spread of the toxin and carry a black box label. A black box label is the strongest safety warning that a medication can carry and is named for the black border that surrounds the warning text.
This side effect has been observed in non-cosmetic uses of botox, primarily in the treatment in spasticity (tight rigid muscle) in children with cerberal palsy where injections in and around the spinal cord with high doses have lead to this effect. While the chance of this occuring in cosmetic applications is not known, it is believed to be an an extremely rare side effect.
In China, a 24 year old female received 200 units of Botox toxin in her legs, in order to treat large calves. Most cosmetic patients with Botox receive 15-45 units of Botox, so this patient received 5 to 8 times the standard dose of botox in a non conventional location. She subsequently developed systemic muscle failure which resolved. It was not clear what type of Botox was used but its believed to not be Botox created by Allergan. Another case of a New Jersey woman who developed systemic issues was the use of an off label use of botox.
What are some take home points from the new approval?
- Only use an approved source of Botulinum toxin. If your injector is injecting in a basement or a non-medical environment, be aware that they are injecting you with the actual Botox. I see alot of patients from other countries who tell me that they had Botox in Asia and it only cost $50 and did not work.
- Make sure a trained health professional is injecting you with Botox. There are plenty of technicians, aestheticians and other unqualifed individuals, including physicians, who do not use Botox properly.There are specific applications for the use of Botox and recommended dilutions for its product. Someone trained in the use of Botox will know this. In addition, knowledge of facial anatomy will allow the injector to specificly target where the Botox should and shouldn’t go. Saving a few dollars to have a lesser qualified person inject you is not worth it from a safety profile as well as just receiving an aesthetic, natural result.
- There is always risk with any procedure. Although the risk of the use of Botox in cosmetic cases is extremely rare, there is some risk. Now most patients I see would gladly accept this risk with the proven benefit of looking younger. I believe that Botox has an extremely safe risk to benefit profile. However, the risks, albeit rare must be mentioned.