Review of ADHD drug approvals highlights gaps between approval process, long-term safety assessment. Over the last 60 years, the U.S. Food and Drug Administration (FDA) approved 20 medications for attention deficit/hyperactivity disorder (ADHD) based on clinical trials that were not designed to study their long-term efficacy and safety or to detect rare adverse events. The study highlights gaps in how the long-term safety of drugs intended for chronic use in children is assessed as part of the FDA approval process.

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