Review of ADHD drug approvals highlights gaps between approval process, long-term safety assessment
"This study doesn't address whether ADHD drugs are safe, though their safety has since been established through years of clinical experience," says study s enior author Kenneth Mandl, MD, MPH, Boston Children's chair in biomedical informatics and population health and director of the Intelligent Health Laboratory in Boston Children's Informatics Program. "Instead, 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." According to the U.S. Centers for Disease Control and Prevention, 11 percent of children in the U.S. between the ages of four and 17 -- or about 6.4 million children -- have been diagnosed with ADHD. On average, children prescribed ADHD medications take them for several years. To understand how extensively the long-term safety of common ADHD medications had been studied before going ...