Botox may have received approval from the Food and Drug Administration for cosmetic use, but now the FDA wants Botox ads pulled until they can tell the truth.
In a Sept. 5 letter to Allergan Inc., Botox’s Irvine, Calif.-based manufacturer, Mary Malarkey of the FDA called the Botox ads misleading, according to the New York Times.<?xml:namespace prefix = o ns = “urn:schemas-microsoft-com:office:office” />
The letter, available on the FDA Web site, said the Botox ads: fail to mention that the wrinkle-smoothing drug is a temporary fix; suggest that Botox can be used to treat all sorts of wrinkles; and don’t state that Botox is approved only for people aged 18 through 65.
Botox works by paralyzing facial muscles that cause expression lines like frown lines, forehead wrinkles and furrows between the eyebrows, according to the Los Angeles Times. The effect is a smoother look that lasts four to six months.
The government approved the drug more than a decade ago to treat crossed eyes and uncontrollable blinking, the New York Times reported. In April, Botox was approved for cosmetic use, but only to treat glabellar lines, the deep vertical lines between the eyebrows.
“It has already become a wildly popular cosmetic procedure in the <?xml:namespace prefix = st1 ns = “urn:schemas-microsoft-com:office:smarttags” />United States, and equally controversial among some medical communities because it uses the derivative from the same toxin that causes botulism and has certain side effects,” according to LookingFit.com.
The FDA letter gave Allergan 10 days to respond to the withdrawal request.
Suki Shattuck, spokeswoman for the company, said it would not stop the ad campaign, but would work with the FDA to “resolve the issue without having to pull the ads,” according to the New York Times.
Shattuck told the Times that Allergan had already spent $50 million this year on the marketing campaign, which includes TV ads, patient brochures and physician education.
The FDA could refer the case to the Justice Department for prosecution should Allergan fail to comply, but Malarkey, who wrote the complaint, told the Times that rarely happens.