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FDAnews Drug Daily Bulletin
Oct. 8, 2008 | Vol. 5 No. 197
FDA Warns Shire for Adderall XR Website, Video on YouTube
The FDA cited Shire Development in a warning letter about a video posted on YouTube.com that featured ABC’s “Extreme Makeover: Home Edition” star Ty Pennington speaking about his positive experiences with Adderall XR, a treatment for attention deficit hyperactivity disorder (ADHD). Pennington says in the video that medicines such as Adderall XR (mixed amphetamine salts) gave him the confidence to achieve his goals. The FDA says although the product has proven effective in clinical trials, the data do not demonstrate the “amazing transformation” claim and the video did not include risk information. The same letter says an Adderall XR webpage lists statistics regarding health consequences of untreated ADHD in an inappropriate manner.
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