Botox ad claims misleading, FDA says; ads will stay, says Allergan

WASHINGTON — Claims regarding the effectiveness and indications of Botox in a new advertising campaign for the drug are in violation of federal law, according to the Food and Drug Administration.

A letter from the FDA to Allergan, the drug’s manufacturer, tells the company to stop broadcasting the ads in question "immediately," but an Allergan spokeswoman said the company would continue to run the ads and work with the FDA to resolve the situation.

The Sept. 5 letter from the FDA to Allergan, the manufacturer of Botox (botulinum toxin type A), said statements contained in patient information brochures and television commercials for Botox Cosmetic fail to adequately specify approved indications, indicate approved age ranges, or state that Botox is only a temporary procedure.

The letter, from FDA's Center for Biologics Evaluation and Research, told the company to "immediately stop all broadcasts of these ads and all other promotional activities for Botox Cosmetic that contain the same or similar presentations" until the materials have been revised to comply with FDA regulations. It gave Allergan 10 days to respond to the agency.

According to a report in the New York Times, a spokeswoman for Allergan said the Irvine, Calif.-based company would not stop the ad campaign, but would work with the agency to "resolve the issue without having to pull the ads."