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If Looks Could Kill: Botox et al Get Updated FDA Warnings

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Washington, DCIt put a new spin on the phrase, 'looks that kill.' When it was first revealed that botox injections had the potential to migrate away from the injection site and cause potentially life-threatening difficulties, it left users taking a long look in the mirror and asking, "Is it all worth it?"

It should be noted that swallowing and breathing difficulties have mostly been reported in children with cerebral palsy treated with botulinium toxin for muscle spasticity—an indication not approved by the US Food and Drug Administration (FDA).

Botox InjectionAdditionally, "no definitive serious adverse event reports of distant spread of toxin effect have been associated with dermatologic use of Botox/Botox Cosmetic at the recommended doses (for frown lines between the eyebrows or severe underarm sweating)," says the FDA in a statement posted on its official web site yesterday "As well, no definitive serious adverse event reports of distant spread of toxin effect have been associated with Botox when used at approved doses for eyelid twitches or for crossed eyes."

In an effort to better inform the consumer as to the risks of using botulinium toxin, the FDA yesterday announced that four popular botulinium toxin products now carry boxed warnings, together with the development of thorough Medication Guides for patients.

The updates grew out of the FDA's previous alerts with regard to botulinium toxin products used primarily for cosmetic enhancement, and a previous mandate issued by the FDA to foster the changes appearing yesterday.

In addition to the boxed warnings, the FDA reveals that three of the four products now have new established drug names, or 'generic' names, in an effort to highlight the fact that botulinium toxin products are not interchangeable due to the diverging units applied for measurement.

The affected products are Botox (new established name: onabotulinumtoxinA), Botox Cosmetic (onabotulinumtoxinA), Myobloc (rimabotulinumtoxinB) and Dysport (abobotulinumtoxinA). The latter was approved in April 2009 with the boxed warning and thus, the original information is considered to be current.

While the generic names have changed, the original formulations of the drugs have not.

Botulinium toxin was originally approved for a limited number of cosmetic purposes. However, its popularity quickly exploded and use of Botox expanded in a market-driven fashion that belied that for which it was originally approved.

Botulinium toxin works cosmetically by temporarily disabling facial muscles that are thought to produce frown lines. However with the potential for the product to migrate away from the original injection site, the affect on muscles integral for survival—such as swallowing and breathing—could prove devastating.



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