ADHD drugs for kids need hallucination warning

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ADHD drugs for kids need hallucination warning

By Rita Rubin, USA TODAY

Visual or tactile sensations of bugs an uncommon, but possible, reaction, study finds.
A Food and Drug Administration advisory committee recommended Wednesday that the agency add information about a possible risk of hallucinations in children to the labels of attention deficit/hyperactivity disorder drugs.

The committee also urged the FDA to develop a consumer-friendly medication guide explaining to parents that they should talk to their child’s doctor about stopping the medication should hallucinations occur.

The panel said the “MedGuide” also should note that ADHD drugs may increase the risk of aggressive behavior, although that can be a component of the disorder itself. And the guide should note that the drugs might increase the risk of heart attack, stroke or sudden death in patients who have undiagnosed heart problems.

Current labeling for the ADHD drugs — Adderall, Focalin, Concerta, Metadate, Methylin, Ritalin and Dexedrine — does not mention the possibility of hallucinations in patients who had no history of them and had taken the usual dose.

“We read case upon case of these children who do experience these hallucinations,” Rosemary Johann-Liang of the FDA’s Office of Drug Safety told the committee. “That is something that really struck all the reviewers.”

Johann-Liang said it’s unlikely that the ADHD drugs are simply unmasking a previously undiagnosed psychiatric disorder that would explain the hallucinations.

The panel did not feel that the risk of hallucinations warranted a “black box” warning, the strongest type of warning, said Pediatrics Advisory Committee chairman Robert Nelson of the department of anesthesia and critical care medicine at The Children’s Hospital of Philadelphia. In 2004, Nelson’s panel did recommend a black box warning about suicidal behavior in children and adolescents who take SSRI (selective serotonin reuptake inhibitor) antidepressants. In that case, he said, there was only “marginal” evidence that the drugs were effective in that age group.

“In this case, you have overwhelming evidence of efficacy,” Nelson said, adding that a black box might unnecessarily scare parents away from treatment.

The panel discussed whether ADHD drugs increased the risk of suicidal thoughts in children and adolescents, a possibility that Kate Gelperin, medical epidemiologist in the FDA’s drug safety office, said could not be ruled out. But the panel did not advise adding that risk to their labels. Thomas Laughren of the FDA division that reviews psychiatric drugs said studies have found that 15% to 20% of adolescents in the general population report having suicidal thoughts.

The ADHD drug Strattera already has a black box warning about suicidal thoughts because of evidence from clinical trials, but no other ADHD drug label carries any information on suicidal thoughts.

Robert Temple, director of the FDA center that evaluates psychiatric drugs, said the agency is likely to follow the panel’s advice.

<<Editors notE>>
Knowing this is some old news for most people who regularly read upon these sort of subjects. Yet I thought it was time for yet another warning… Can u imagine how kids react to this stuff? I mean, Kids are supposed to be hyperactive, or better, they are supposed to be themselves (some mellow, some not, it’s just the way nature flows). But in this case giving them pills might just have some nasty side-effects which could endanger the normal development of yet another kids life…

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