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ADHD Drug To Be Tested On Four-Year-Olds

Clinical trials for a new ADHD drug have raised more than a few eyebrows.

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By McCarton Ackerman

06/16/14

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A new ADHD drug could soon be making its way to the American drug market, but the Food and Drug Administration has raised eyebrows by requesting that it be tested on four- and five-year-old children.

Vyvanse, made by London-based pharmaceutical company Shire, is already a best-selling drug on the other side of the pond. But because it’s only indicated for use in children over the age of six with ADHD, the FDA has asked Shire to begin clinical trials of the drug in younger children. The first of three clinical trials will begin next year. Vyvanse is also currently used medically to treat binge-eating disorders. It’s currently the top-selling ADHD drug for Shire, with over $1.2 billion in sales last year.

Shire said in a statement that they are “committed to continuing to add to the scientific body of knowledge about ADHD treatment options for patients. Additional efficacy and safety data will help clinicians and parents make informed treatment decisions for preschool-age children with ADHD." Giving ADHD drugs to children as young as four may seem excessive, but methylphenidate, which is sold as Concerta and Ritalin, has been endorsed for use at that age by the American Academy of Pediatrics.

However, these medications have been shown to suppress growth during puberty, and can also cause liver damage, weight loss, and suicidal thoughts in older users. Despite this, recent estimates from an official at the Center for Disease Prevention and Control also indicate that over 10,000 toddlers in the U.S. are being given ADHD medication outside of the current recommended guidelines.

FDA spokeswoman Stephanie Yao said via email that the clinical trials were important in order for doctors to be able to properly prescribe medications and for parents to be able to identify side effects.

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