{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,20]],"date-time":"2026-06-20T14:31:11Z","timestamp":1781965871232,"version":"3.54.5"},"reference-count":19,"publisher":"American Academy of Pediatrics (AAP)","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2009,2,1]]},"abstract":"<jats:p>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.<\/jats:p>\n               <jats:p>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.<\/jats:p>\n               <jats:p>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 &amp;gt;800 reports of adverse events related to psychosis or mania. In \u223c90% 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.<\/jats:p>\n               <jats:p>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.<\/jats:p>","DOI":"10.1542\/peds.2008-0185","type":"journal-article","created":{"date-parts":[[2009,1,26]],"date-time":"2009-01-26T12:23:44Z","timestamp":1232972624000},"page":"611-616","source":"Crossref","is-referenced-by-count":119,"title":["Hallucinations and Other Psychotic Symptoms Associated With the Use of Attention-Deficit\/Hyperactivity Disorder Drugs in Children"],"prefix":"10.1542","volume":"123","author":[{"given":"Andrew D.","family":"Mosholder","sequence":"first","affiliation":[{"name":"Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kate","family":"Gelperin","sequence":"additional","affiliation":[{"name":"Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tarek A.","family":"Hammad","sequence":"additional","affiliation":[{"name":"Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathleen","family":"Phelan","sequence":"additional","affiliation":[{"name":"Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rosemary","family":"Johann-Liang","sequence":"additional","affiliation":[{"name":"Health Resources and Services Administration, Department of Health and Human Services, Rockville, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"417","published-online":{"date-parts":[[2009,2,1]]},"reference":[{"key":"2021120822561957700_R1","unstructured":"Centers for Disease Control and Prevention. Mental Health in the United States: prevalence of diagnosis and medication treatment for attention-deficit\/hyperactivity disorder\u2014United States, 2003. MMWR Morb Mortal Wkly Rep.\u20082005;54(34):842\u2013847. Available at: www.cdc.gov\/mmwr\/preview\/mmwrhtml\/mm5434a2.htm. Accessed November 21, 2008"},{"key":"2021120822561957700_R2","unstructured":"US Food and Drug Administration. Pediatric Advisory Committee Meeting, June 30, 2005. Available at: www.fda.gov\/ohrms\/dockets\/ac\/05\/briefing\/2005-4152b2.htm. Accessed November 21, 2008"},{"key":"2021120822561957700_R3","unstructured":"US Food and Drug Administration. Pediatric Advisory Committee Meeting, March 22, 2006. Available at: www.fda.gov\/ohrms\/dockets\/ac\/06\/briefing\/2006-4210B-Index.htm. Accessed November 21, 2008"},{"key":"2021120822561957700_R4","unstructured":"FDA MedWatch. Attention deficit hyperactivity disorder (ADHD) drug products: medication guides required to alert patients to possible cardiovascular and psychiatric risks. February 21, 2007. Available at: www.fda.gov\/medwatch\/safety\/2007\/safety07.htm#ADHD. Accessed November 21, 2008"},{"key":"2021120822561957700_R5","unstructured":"Cephalon, Inc. Provigil prescribing information. Available at: www.provigil.com\/Media\/PDFs\/prescribing_info.pdf. Accessed November 21, 2008"},{"key":"2021120822561957700_R6","doi-asserted-by":"crossref","unstructured":"Vetter VL, Elia J, Erickson C, et al. Cardiovascular monitoring of children and adolescents with heart disease receiving stimulant drugs. A scientific statement from the American Heart Association Council on Cardiovascular Disease in the Young Congenital Cardiac Defects Committee and the Council on Cardiovascular Nursing. 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