Shire To Comply With FDA Request To Test ADHD Drug On Preschoolers

Shire, which produces the ADHD drug Vyvanse, has agreed to test the drug on preschool children at the request of the FDA. The FDA is concerned about the increase in ADHD diagnoses and drug prescriptions for young children and wants to learn if Vyvanse can produce positive outcomes for the young patients that it treats.

Gwen Fisher, a spokesperson for Shire, has said that the company is currently working on the design of multiple clinical trials, which will include children ages 4 and 5. One study will look to determine how well the body absorbs the drug, and how it is broken down and excreted once ingested. Another study will look to test for the drug’s safety and efficacy, while third study will test for long term safety of the drug.

The CDC announced that the number of children diagnosed with ADHD increased 41 percent from 2003 to 2011. That brings the present number of children diagnosed with the disorder up to 6.4 million as of 2011—or 11 percent of all children ages 4-17. The FDA has not yet said if it will take any particular action as a result of the study, but it could put in place stricter regulations on the prescription and usage of ADHD drugs in the future. Shire also produces the ADHD drug Adderall, currently the only ADHD drug approved for use in children under 6 years of age. The FDA is interested to see how Vyvanse affects young children, since it is believed that many young patients are still treated with the drug.

While ADHD patients typically have a difficult time controlling their impulses, there are side effects which are not yet fully understood. Those potential side effects include growth suppression in children, hallucinations, mania, and delusions.