Psychiatric Adverse Events with ADHD Drugs

In response to discussions by the U.S. Food and Drug Administration’s Pediatric Advisory Committee in 2005, FDA researchers studied psychotic and manic adverse events related to drugs used to treat ADHD. The researchers followed two approaches.

First, manufacturers of amphetamine, methylphenidate, atomoxetine, and modafinil preparations were asked to review their electronic databases to cull psychotic or manic events occurring during or within 48 hours after treatment in double-blind, placebo-controlled, pediatric ADHD studies. The manufacturers identified 49 trials involving 3990 placebo recipients and 5717 medication recipients. Eleven events occurred with the active drugs (0.19% of recipients) and none with placebo.

Then, the FDA team exam…