FDA Warns Shire That ADHD Drug Promo Magnet Goes Too Far on Safety

In a warning letter posted online May 17, the Food and Drug Administration told Shire Pharmaceuticals Inc. that a promotional magnet for Vyvanse misbrands the drug by failing to highlight its full indication and the serious risks associated with its use.

The drug, Vyvanse (lisdexamfetamine dimesylate) Capsules, is used to treat attention deficit hyperactivity disorder (ADHD) in children. The agency letter noted that the drug has been shown to be effective in the six-to-12 age group.

According to FDA, the magnet was typically displayed in such a way that a sales representative’s business card would be placed in a plastic ...