FDA says Botox ads misleading

LOS ANGELES - The US Food and Drug Administration said magazine ads for the wrinkle-smoothing drug, Botox, are misleading and instructed the drug's maker, Allergan, to stop running them.

A spokeswoman for Allergan said the company thought it was complying with the FDA's guidance and "ultimately believes we can easily address the request".

The ads falsely identify the injected drug as a cosmetic treatment, fail to reveal important facts about its use and minimise its risks, the regulatory agency said in a letter posted on the FDA's website.

The agency also said Allergan, which forecast Botox sales at up to US$580 million ($999.48 million) this year, misleadingly suggested that the drug was effective for conditions such as temporary treatment of frown lines that go beyond its approved use as a treatment for improving brow furrows.

Three versions of the print ads have run in publications such as Newsweek and Glamour magazines, Allergan said.

The FDA last September issued a similar warning to Allergan, citing print and television ads that failed to emphasise that Botox was a temporary fix and that suggested it could be used to treat all kinds of wrinkles.

Allergan spokeswoman Christine Cassiano said one of the company's responses to that citation was to specify in the first paragraph of its 2003 ads that Botox was used for "frown lines between the brows" but subsequent references shortened that phrase to "frown lines".

The issue of describing the drug as a cosmetic treatment is less clear. "Part of the difficulty is that the name of the product is Botox Cosmetic ... ," Cassiano said. "This is a physician-administered product. We don't want to create the misperception that Botox is available over the counter."

She said Allergan is not running television ads for Botox, although ads were broadcast earlier in the year.

The FDA instructed the company to stop all ads and other promotions that contain the misleading claims and to respond to the letter in writing.

Approved since 1989 for eye-muscle disorders, and used for years "off-label" to freeze wrinkles, Botox was approved by the FDA last year for temporary improvement in the appearance of "moderate to severe" frown lines between the eyebrows.

Botox, a purified form of the toxin that causes botulism food poisoning, blocks the release of a chemical by nerve cells that signal muscle contraction. By interfering with the underlying muscles' ability to contract, existing frown lines are smoothed out.

- REUTERS