Looking into some articles in the press on Botox and “Bad Drugs,” there is a misconception that warrants explanation. Allergan and other drug companies have a significant market interest in their products. Their marketing will of course imply that their drug is superior or that alternate drugs are unsafe. For better or worse, this is the nature of advertising.

Let’s look at the history of Botox Cosmetic TM:

Botulinium Toxin A (at the time named Botox TM) was approved by the FDA for use in blepharospasm (to decrease spastic movements of the muscles of the eye) in 1989. It was used “Off-label” soon thereafter by plastic surgeons and other physicians to effect cosmetic muscle paralysis.

What is “Off-Label?”

The “Off-label” use of a drug is utilization of a drug for a purpose for which is not FDA-approved. Between 1989 and 2002, Botox TM was used “Off-label” by a number of physicians essentially every time it was used for cosmetic purposes prior to being FDA-approved.

Since Botox TM was FDA-approved for cosmetic use in 2002, Allergan has promoted it over other competing products as the “only FDA-approved” Botulinium toxin for cosmetic use. The inference is that other products are unsafe. To berate non-FDA-approved Botulinium products ignores the history of Botox Cosmetic TM.

Myobloc TM is Botulinium toxin B. It is currently FDA-approved for cervical dystonia (to diminish neck spasms). It is currently being used “Off-label” for cosmetic purposes just as Botox TM was for years. It is as safe now as Botox was when it was being used “Off-label.”

Best Regards,

John Di Saia MD

Related:
My 2002 Botox FDA Approval Newspaper Editorial