Intuniv materials get FDA warning

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Patient materials for Shire's ADHD drug Intuniv presented unsubstantiated effectiveness and superiority claims and downplayed important risk info, said the FDA's Division of Drug Marketing, Advertising and Communication.

In a June 22 untitled letter, DDMAC asked Shire to stop giving out an Intuniv “patient starter kit.” The agency said materials “use large and colorful headers to highlight benefits of Intuniv therapy, including a prominent and compelling image of a child in a large monster suit, while the risk information appears in small font and in single-spaced paragraph format, and in many cases only appears at the end of each piece.”

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