Cited by 155Attention Deficit Hyperactivity DisorderPharmacovigilance and Adverse Drug ReactionsSchizophrenia research and treatment

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

Mosholder, Andrew D., Gelperin, Kate, Hammad, Tarek A., Phelan, Kathleen, Johann-Liang, Rosemary·2009·Pediatrics

DOI 10.1542/peds.2008-0185

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Abstract

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 p…

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Authors: Mosholder, A. D., Gelperin, K., Hammad, T. A., Phelan, K., & Johann-Liang, R.
Affiliations: United States Food and Drug Administration (US)
Health Resources and Services Administration, Department of Health and Human Services, Rockville, Maryland
Corresponding author: Gelperin, Kate
ORCID: Mosholder, Andrew D.
Hammad, Tarek A.
Venue: Pediatrics
Publisher: American Academy of Pediatrics (AAP)
Published: 2009-02-01
Volume: 123
Issue: 2
Pages: 611-616
ISSN: 0031-4005 (ISSN-L)
1098-4275
DOI: 10.1542/peds.2008-0185
OpenAlex: W2092853583
Cited by: 155
References: 15
Citations by year: 2026: 3 · 2025: 5 · 2024: 10 · 2023: 4 · 2022: 8 · 2021: 6 · 2020: 15 · 2019: 18 · 2018: 7 · 2017: 10 · 2016: 7 · 2015: 12 · 2014: 8 · 2013: 6 · 2012: 8
FWCI: 7.38
Type: journal article
Language: en
Open access: closed
Locations: PEDIATRICS (publishedVersion)
PubMed (publishedVersion)
Funders: Eli Lilly and Company
Topics: Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
Keywords: attention deficit hyperactivity disorder, psychostimulants, psychosis, mania, hallucinations, adverse drug reactions, drug safety in children, post-marketing surveillance, FDA Adverse Event Reporting System
MeSH terms: Attention Deficit Disorder with Hyperactivity, Child, Female, Hallucinations, Humans, Male, Psychoses, Substance-Induced, Adverse Drug Reaction Reporting Systems

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

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