Nearly 1 in 9 children have been diagnosed with attention deficit hyperactivity disorder, but drugs they take to treat symptoms — which include methylphenidate (Ritalin) and amphetamine/dextroamphetamine (Adderall) — have not been investigated in drug clinical trials to determine whether they’re safe to take long term, according to a new study by Boston Children’s Hospital researchers. The study’s authors emphasized that this doesn’t mean ADHD drugs pose safety risks but that the initial approval trials — which made the drugs available to thousands of children for long-term use — largely ignored the possibility of safety issues.
The researchers identified 32 clinical trials on the 20 ADHD drugs approved by the US Food and Drug Administration and found that only five of the trials focused on drug safety and that each drug was tested on an average of 75 patients before getting FDA approval. The average length of each trial was just four weeks. The study was published last Wednesday in the journal PLOS One.
“This is a wake-up call for what’s lacking in the drug approval process and what we want to see in the future,” said study coauthor Dr. Kenneth Mandl, chair of biomedical informatics at Boston Children’s Hospital. “Our findings are particularly troubling since these drugs are so widely used and used for years, not weeks.” D.K.