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<<   作成日時 : 2009/01/28 00:40   >>

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画像 ADHD(注意欠陥・多動性障害)治療薬により、小児に幻覚が出現する可能性がある。製薬企業により行われた49の臨床研究において、何人かの患者が精神症状と躁状態をおこした。虫や蛇が身体に這っているという幻覚がみられた例もある。薬のリスクについての詳しい分析が提供される。Novartis AGのリタリンとFocalin XR、Shire Plc's Adderall XR と Daytrana patch、Johnson & Johnsonのコンサータ、Eli LillyとCo's Strattera と Celltech Pharmaceuticals Inc'sのMetadate CD。
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米FDAがADHD治療薬の副作用を調査/リタリン
http://kurie.at.webry.info/200709/article_44.html
増加する10代のADHD/注意欠陥多動性障害
http://kurie.at.webry.info/200807/article_51.html
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ADHD Drugs Can Cause Hallucinations in Some Kids
Drugs Like Ritalin, Adderall Have Psychiatric Side Effects in Some Children
By Julie Steenhuysen
January 26, 2009
http://abcnews.go.com/Health/MindMoodNews/WireStory?id=6729337&page=1

ADHD Drugs Can Cause Hallucinations in Some Kids
ADHD drugs may bring about hallucinations in some young patients, new research suggests.
(Getty/ABC News)

CHICAGO (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.
"Patients and physicians should be aware of the possibility that psychiatric symptoms consistent with psychosis or mania" might arise in the course of treatment, Dr. Andrew Mosholder and colleagues wrote in the journal Pediatrics.
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.
Millions of children use drugs to treat symptoms of ADHD, which affects about three to seven percent of U.S. children.
ADHD is marked by restlessness, impulsiveness, inattention and distractibility that can interfere with a child's ability to pay attention in school and maintain social relationships.
"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.
He said children under age 10 are susceptible to negative drug side effects in the same way that older adults are.
"We know that medications that affect neurochemicals in your brain to increase your attention and make you less impulsive also can have an effect on other neurochemicals in your brain that affect mood," he said.
Both Koplewicz and FDA researchers urged doctors to discuss the potential side effects with parents and children to help ease their anxiety if such symptoms should occur.

(Editing by Maggie Fox and Alan Elsner)
Copyright 2009 Reuters News Service. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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PEDIATRICS Vol. 123 No. 2 February 2009, pp. 611-616 (doi:10.1542/peds.2008-0185)

ARTICLE

Hallucinations and Other Psychotic Symptoms Associated With the Use of Attention-Deficit/Hyperactivity Disorder Drugs in Children

Andrew D. Mosholder, MD, MPHa, Kate Gelperin, MD, MPHa, Tarek A. Hammad, MD, PhD, MSc, MSa, Kathleen Phelan, RPha and Rosemary Johann-Liang, MDb

a Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland
b Health Resources and Services Administration, Department of Health and Human Services, Rockville, Maryland

OBJECTIVES. To gain a better understanding of the capacity of psychostimulant medications to induce adverse psychiatric reactions and determine the frequency of such reactions, we analyzed postmarketing surveillance data and clinical trial data for drugs, either approved or under development, for the treatment of attention-deficit/hyperactivity disorder.

METHODS. The US Food and Drug Administration requested manufacturers of drugs approved for attention-deficit/hyperactivity disorder or with active clinical development programs for that indication to search their electronic clinical trial databases for cases of psychosis or mania using prespecified search terms. The manufacturers supplied descriptions of clinical trials, numbers of patients exposed to study drug, and duration of exposure to permit calculations of incidence rates. Independently, cases of psychosis or mania in children and adults for drugs used to treat attention-deficit/hyperactivity disorder from the Food and Drug Administration Adverse Event Reporting System safety database were analyzed. Manufacturers were asked to conduct similar analyses of their postmarketing surveillance databases.

RESULTS. We analyzed data from 49 randomized, controlled clinical trials in the pediatric development programs for these products. A total of 11 psychosis/mania adverse events occurred during 743 person-years of double-blind treatment with these drugs, and no comparable adverse events occurred in a total of 420 person-years of placebo exposure in the same trials. The rate per 100 person-years in the pooled active drug group was 1.48. The analysis of spontaneous postmarketing reports yielded >800 reports of adverse events related to psychosis or mania. In ~90% of the cases, there was no reported history of a similar psychiatric condition. Hallucinations involving visual and/or tactile sensations of insects, snakes, or worms were common in cases in children.

CONCLUSIONS. Patients and physicians should be aware that psychosis or mania arising during drug treatment of attention-deficit/hyperactivity disorder may represent adverse drug reactions.

Key Words: ADHD • adverse drug reactions • drug safety • psychiatric issues in primary care

Abbreviations: ADHD―attention-deficit/hyperactivity disorder • CI―confidence interval • FDA―Food and Drug Administration • PAC―Pediatric Advisory Committee • AERS―Adverse Event Reporting System

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