September 9, 2002 --LOS ANGELES - Print and television ads
for the wrinkle-smoothing drug Botox are misleading and should be pulled
until they are changed, the US Food and Drug Administration told the
drug's maker Allergan Inc.
The ads fail to emphasize that Botox is a temporary fix for wrinkles,
suggest incorrectly that it can be used to treat all kinds of wrinkles and
do not mention that the drug is approved only for people between the ages
of 18 and 65, the regulatory agency said in a Sept. 5 letter to the
company and posted on the agency's Web site.
The FDA instructed the company to immediately stop all broadcast ads
and other promotional activities that contain misleading claims.
Officials at Allergan, based in Irvine, California, could not be
immediately reached for comment.
Botox, a purified form of the toxin that causes botulism food
poisoning, smooths out wrinkles by interfering with neurotransmitters and
relaxing muscles.
Approved since 1989 for eye muscle disorders, and used for years
``off-label'' to freeze wrinkles, Botox was officially approved by the FDA
in April for temporary improvement in the appearance of moderate to severe
brow furrows.
The FDA said a brochure stating, ``It seems like everybody is talking
about Botox Cosmetic, the highly effective, non-surgical procedure that
can dramatically reduce your toughest wrinkle within 7 days,'' misleads
because it does not state that the effect is temporary.
``Please immediately cease distribution of these, and similarly worded,
materials and revise these statements to clearly emphasize the temporary
duration of this product and to appropriately identify the approved
indication for use, e.g. 'those tough lines between your eyebrows,''' Mary
Malarkey, of the FDA's office of compliance and biologics quality, said in
the letter.
The FDA also said Allergan was misleading consumers with statements
like, ``If doing all you can to look your best is important to you, Botox
Cosmetic may be for you,'' because they do not clearly define the age
range it is approved for.
The agency singled out TV ads that focus attention on complexion and
image, make repeated references to age and make the statement, ``Ask your
dermatologist or plastic surgeon about Botox Cosmetic.''
The FDA also warned Allergan that dilution instructions for doctors
posted on a company Web site promote several dilutions and doses that are
not approved for cosmetic procedures.
The FDA requested that the company respond by Sept. 15.
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