Even though about 10% of American children have been diagnosed with ADHD and most are taking stimulant medications for it, Boston Children’s Hospital researchers report in PLOS One that there have been no studies into the long-term safety of these drugs. “This is a wake up call for what’s lacking in the drug approval process and what we want to see in the future,” study co-author Dr. Kenneth Mandl told the Boston Globe. “Our findings are particularly troubling since these drugs are so widely used and used for years, not weeks.”
The Boston Children’s Hospital researchers identified 32 clinical trials on the 20 ADHD drugs approved by the US Food and Drug Administration. These trials involved on average just 75 patients, only five focused on drug safety, and the average length of each trial was just four weeks.
ADHD drugs lacking in safety studies, Boston researchers find (Boston Globe, July 9, 2014)
Premarket Safety and Efficacy Studies for ADHD Medications in Children (Bourgeois, Florence T. et al. PLOS One. July 09, 2014 DOI: 10.1371/journal.pone.0102249)