FDA Orders Extra Warning Labels on Botox

Even though there have not been any reports of serious side effects of Botox for cosmetic purposes, the US Food and Drug Administration has ordered manufacturer Allergan to put extra warning labels on the product so that consumers are well-aware of potential side effects.

This initiative has been put into place after researchers discovered that Botox can spread outside of the treated area when it is used to treat diseases such as cerebral palsy.  Some of the documented side effects of Botox outside of cosmetic use include breathing problems, drooping eyelids, muscle weakness and double vision.

According to Dr. Russell Katz of the FDA’s Center for Drug Evaluation and Research, “Updated labels for this class of products will help health care professionals and patients better understand the risks and benefits. Botulinum toxin products have benefits but can cause serious health problems and it is important that anyone who administers or uses these products understands these risks.”

The FDA warns that there is an inherent risk of Botox migrating to distant parts of the body, and in some cases, can pose a life-threatening condition. In addition to the additional label warnings, Allergan will need to send doctors a letter or comprehensive guide that covers all of the potential risks and health problems involved with the injectable at the time of the injection.

The FDA is requiring additional labels and warnings on both cosmetic Botox and medicinal Botox packages. Allergan must comply with these new guidelines or risk having the product pulled from the market.

Botox had worldwide sales of $1.3 billion in 2008, according to The New York Times. Another new contender on the market is Dysport, an injectable that provides similar results as Botox. Both products must now meet these new labeling requirements and standards in order to maintain a presence in the cosmetic surgery market.

Further Reading

  • Reducing the signs of aging with facial treatments such as microdermabrasion and dermal fillers can provide temporary results, but innovative procedures such as Fraxel C02 Laser Treatment show more promise for those who want to get rid of fine lines and wrinkles for the long-term.

  • A new TV show in Australia called The Shire recently spotlighted plastic surgery and featured the stars of the show having now qualms about treatments. The show’s stars Sophie and Vernesa aren’t afraid to show off their fake breasts in revealing tops and dresses, and are both sporting the infamous lip-enhanced pouts. Vernesa admits that she’s been told not to have any more filler treatments in her lips to prevent her lips from touching her nose. She undergoes Botox for the first time on camera.

  • Kim Kardashian continues to shoulder rumors about having plastic surgery, and some people report that the star has had multiple procedures including liposuction, breast augmentation, and Botox. Kim has admitted to having Botox, as well as VelaShape treatments designed to treat cellulite and smooth out the skin. She reportedly undergoes laser facial treatments to maintain her smooth skin and ward off the effects of aging. But has she really gone under the knife for more extensive procedures?