The US Food and Drug Administration has warned Eli Lilly over a television advertisement for its attention deficit hyperactivity disorder drug, Strattera (atomoxetine), which is says “inadequately communicates the indication for Strattera” and minimises the risks associated with the drug’s use.
In a letter dated 14 June, but posted on its website yesterday, the FDA said that the 60-second television advertisement “potentially broadens the use of the drug beyond the indicated patient population.” The agency asked Lilly to immediately stop broadcasting the ad in question.
Post-marketing studies of Strattera have linked its use to rare cases of severe liver damage [[20/12/04d]], and the FDA said that the ad minimized such serious risks with its “competing graphics” and distracting visual content.
The ad, entitled “Videogame”, features a person in a variety of situations as seen through the screen of a videogame, including leaving the house; walking to his car and going back to the house for his car keys. These scenes are presented with a box on the screen that describing each behavior with words such as “disorganised” or “distracted.” After the person has taken Strattera, their “score” in the videogame improves, with words such as “sustained attention bonus” flashing on the screen.