Archive for July, 2008

Botox Safety Issues

July 29, 2008

Botox is botulinum, BUT botulinum is not Botox!!!


One of the advantages of practicing in Manhattan, the Hamptons, and Aspen, is that whenever an interesting story hits the news, my patient population is bound to know about it.  They are not only savvy, but cover a vast geographic area and often travel to and from my office destinations.  So, if it’s in the news, they are bound to hear about it and sure to inquire about it.


This blog is dedicated to the recent report of botulinum being detected in mice brains after cutaneous injection near the mice’s whiskers.  FIRST, it is important to note that this report is a contradiction to a prior study done by Allergan. SECOND, as the title of this blog suggests, not all botulinum is Botox.  I remember from my high school math classes, that we learned about “logic.”  Basically, if p = q, it does not mean that q = p.  In other words, if Botox is botulinum, it does not mean that botulinum is botox.


To further explain, Botox is a specific version of botulinum toxin, consisting of approximately a 900 kd molecule.  Botox is a specific from of botulinum type A, consisting of light (50kd) and heavy chain (100kd) surrounded by accessory proteins.  These proteins prevent diffusion of the Botox, as does the relatively large size of the Botox.  On the other hand, the recently reported mice story in the news consisted of a botulinum molecule weighing 150 kd, or approximately 1/7th the size AND lacking the aforementioned surrounding proteins; therefore, it is not that surprising that it would be able to diffuse so much more.  In addition, the mice study utilized a mega dose which was approximately 150 times the dose given to patients, when normalized for body weight. 


An example of a differing formulation of botulinum soon to hit the US market is called myobloc, which is a specific form of botulinum-type B.  It can have similar effects as Botox but is completely different in structure and potency.  For example, one vial of Botox consists of 100 units, yet one vial of myobloc will consist of 5000 units.  So, a patient will require a much greater number of units of myobloc than of Botox, to get the same result.


Additional facts about Botox are the following:


  • Botox was first approved for COSMETIC use in the USA in 2002
  • Since then, more than 16 million procedures have been performed for aesthetic/cosmetic purposes
  • Prior to 2002, Botox was already being widely used for off-label cosmetic purposes
  • Botox has also been approved and used for medical purposes/neurological diseases/spasms for approximately 20 years   
  • In one study of 1000 patients, 97% were “definitely satisfied” with their Botox treatment


In conclusion, the study that hit the news was not specifically about Botox!