More Trouble for Botox...

It’s been a tough week for Botox.  First, the FDA approved a competitor drug called Reloxin. Then, the agency said both drugs, along with a third called Myobloc, should carry "black-box warnings" to alert patients and doctors to serious safety risks.

What do I think of this ruling?  Nonsense.  This is cover-your-butt politics.

Botox, Reloxin, and Myobloc are each based on chemical ingredients collectively known as botulinum toxin.  While this chemical mix does cause the serious illness botulism, be assured that the overwhelming majority of people who get Botox and similar drugs don’t get botulism.

Nevertheless, some apparent cases have been reported, particularly in children being treated for cerebral palsy.  Remember, however, that these children are not healthy to begin with; they are much smaller than adults; and they are receiving dosages much higher (sometimes 10-fold higher) than the cosmetic dosages used in the face.

(By the way, the use of poisons for medical therapy has a long track record....  A common blood thinner called Coumadin is also the active ingredient in rat poison.  The curare drugs are not only Amazonian arrow poisons, but are also important anesthesia agents for muscle relaxation.  Many of the chemotherapies used to treat cancer are poisonous in excessive dosages.)

So, do I still think that Botox, et. al., are safe when used in healthy adults to treat facial wrinkles?  Yes.  Do I still use Botox on my office staff, my personal friends, my wife, and my mother?  Yes, yes, yes, and yes!

In the FDA's statement, the agency did admit that it has not seen serious problems with approved cosmetic uses of Botox or Reloxin.  Nevertheless, the shizophrenic FDA does require the black-box warning for all uses of the drug.

The bottom line:  Some lawyer is trying to cover the FDA's butt with this advance warning.  Ignore him.

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