Intuniv patient kit draws DDMAC untitled letter
In a June 22 untitled letter posted today, DDMAC asked Shire to stop giving out an Intuniv “patient starter kit,” including a parent guide, titration guide and ADHD support guide as well as in-office brochures. The agency said materials, which feature images of a child in a monster suit and “before and after” images, give the impression that the drug will improve individual behavioral problems in children with ADHD. That impression isn't supported by the science, said FDA.
The parent guide also suggested that the drug “improved symptoms day and night,” which the agency said “misleadingly implies that Intuniv is efficacious for a full 24-hour day.”
Some materials failed to present risk information, the agency found. Among other incidences, DDMAC noted that the front side of a branded brochure holder presented effectiveness claims for the drug but fails to present risk information – which is printed on the back of the holder, where the letter noted “it is unlikely to draw the reader's attention.”
“Moreover, the promotional materials further minimize the risks of Intuniv by failing to present risk information with a prominence and readability reasonably comparable with the presentation of claims relating to the effectiveness of the drug,” said the letter. “Specifically, the promotional 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.”