-- Scott Roberts
THURSDAY, Sept. 12 (HealthDay News) -- U.S. Food and Drug
Administration approval for Cosmetic Botox (onabotulinumtoxinA) has
been expanded to include moderate-to-severe lateral canthal lines,
the medical term for so-called "crow's feet" lines that surround
The drug was approved in 2002 for the temporary improvement of
so-called "frown lines" between the eyebrows, the agency said in
news release. The drug, made from the bacterium that causes
botulism, keeps affected muscles from tightening, reducing the
appearance of wrinkle lines.
The injected drug may now be given at the same time to reduce
both crow's feet and frown lines, the FDA said.
The drug's safety and effectiveness in treating crow's feet were
established in clinical studies involving 833 adults, who were
either given Cosmetic Botox or a non-medicinal placebo. Those given
Cosmetic Botox showed a greater improvement in crow's feet lines,
the agency said.
The most common side effect of the drug when used for this
purpose was swelling (edema) of the eyelids, the FDA said.
The non-cosmetic version of Botox has been approved to treat
conditions including chronic migraine, severe underarm sweating,
eyelid spasm and a certain misalignment of the eyes. The drug, in
both its cosmetic and non-cosmetic forms, contains a boxed label
warning of the possibility of botulism-like symptoms. These include
swallowing and breathing difficulty, which could be
life-threatening, the FDA said.
However, the agency said there has been no confirmed case of
"toxin spread" as long as either form of Botox were used at the
recommended dosages for FDA-approved reasons.
Botox is manufactured by Allergan, based in Irvine, Calif.
The FDA has more about
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