Research shows FDA approval process for ADHD drugs does not study long-term safety or efficacy

Researchers have highlighted a flaw in the US Food and Drug Administration’s approval process for attention deficit/hyperactivity disorder (ADHD) medicine, according to a report published in PLOS ONE journal.

The Boston Children’s Hospital study shows that 20 medications approved for ADHD did not study their long-term efficacy and safety, and did not detect rare adverse effects.

Kenneth Mandl, chair in biomedical informatics at Boston Children’s Hospital, said: "This study doesn't address whether ADHD drugs are safe, though their safety has since been established through years of clinical experience. We point to the need for an agenda emphasizing improved assessment of rare adverse events and long-term safety through post-marketing trials, comparative effectiveness trials and more active FDA enforcement."