From
Reuters:
Drugs for attention deficit hyperactivity disorder can cause children to have hallucinations even when taken as directed, U.S. government researchers said on Monday.
U.S. Food and Drug Administration researchers analyzed data from 49 clinical studies conducted by makers of the drugs and found they can cause psychosis and mania in some patients, including some with no obvious risk factors. In some cases, children hallucinated that worms, bugs or snakes were crawling on them.
Their analysis provides fresh detail about known risks of the
drugs, which include Novartis AG's Ritalin and Focalin XR, Shire Plc's Adderall XR and Daytrana patch, Johnson & Johnson's Concerta, Eli Lilly and Co's Strattera and Celltech Pharmaceuticals Inc's Metadate CD.
It also includes data on Cephalon Inc's modafinil, sold as Provigil, a narcolepsy drug that was rejected as an ADHD treatment in children.
FDA spokeswoman Sandy Walsh said the data formed the basis for recent warnings about psychiatric side effects that have been added to product labels in recent years.
"The numbers of cases of psychosis or mania in pediatric clinical trials were small," Mosholder and colleagues wrote. "However, we noted a complete absence of such events with placebo treatments."
In one account, they described a 7-year-old girl who took an 18 mg dose of Strattera or atomoxetine who started talking nonstop within hours of taking her first dose.
"Two hours after taking her second dose of atomoxetine, the patient started running very fast, stopped suddenly, and fell to the ground. The patient said she had 'run into a wall' (there was no wall there)," they wrote.
"These adverse side effects are rare," said Dr. Harold Koplewicz of New York University Child Study Center, who was not involved in the study, adding that they are reversible, "Once you stop the medicine, the side effects go away," he said in a telephone interview.