Monday, October 5, 2009

In the news: Allergan suing FDA


According to an April 11 story in the NY Times by Natasha Singer, almost half of Botox's global sales are from off-label uses.

Botox is only "approved by the FDA for use cosmetically as a wrinkle treatment and medically for eye-muscle disorders, excessive underarm sweating and cervical dystonia in adults, which causes abnormal head positions and neck pain."


For wrinkles, by the way, it's only indicated for glabella and crows feet, anything other than that is considered off label.  Using it elsewhere is legal, but it's not legal for Allergan to market said uses, or educate doctors about how it can be used off-label.

The LA Times is reporting that Allergan is suing the FDA, arguing that the right to free-speech should allow them to share information about off-label uses with doctors.  From the article:


"Allergan says companies should be allowed to provide physicians with information on risks, benefits, dosage levels, limitations and what patients to treat in off-label uses, said Caroline Van Hove, an Allergan spokeswoman.

The company has compiled information about off-label uses of Botox, including benefits and safety issues, and would like to provide it to doctors, Van Hove said."



In my experience, Botox is pretty commonly used for the remainder of the forehead (outside of the glabellar area), it's used to raise the outer portion of the eyebrows, and less commonly used in the lips in conjuction with filler for the lips to soften lines and make the fillers last longer.

I've also seen quite a few patients request it for underarm and hand sweating.

Thanks for reading,

Dr. Andrew Smith
Irvine & Corona, California

1 comments:

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