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Abstract
Clinical trial and postmarketing surveillance data for drugs used in treatment of attention deficit hyperactivity disorder were analyzed to determine the frequency of hallucinations and other psychotic side effects, in a study at the US Food and Drug Administration, and Department of Health and Human Services, Maryland.
Highlights
ADHD has received little attention until recently, isolated reports of cases are cited in the literature for the past 40 years
Clinical trial and postmarketing surveillance data for drugs used in treatment of attention deficit hyperactivity disorder were analyzed to determine the frequency of hallucinations and other psychotic side effects, in a study at the US Food and Drug Administration, and Department of Health and Human Services, Maryland
Hallucinations occurred during doubleblind treatment with every class of compound except Adderall XR, but psychosis/mania events were reported with open-label Adderall XR
Summary
ADHD has received little attention until recently, isolated reports of cases are cited in the literature for the past 40 years. Clinical trial and postmarketing surveillance data for drugs used in treatment of attention deficit hyperactivity disorder were analyzed to determine the frequency of hallucinations and other psychotic side effects, in a study at the US Food and Drug Administration, and Department of Health and Human Services, Maryland. In a search of electronic databases of 49 randomized, controlled clinical pediatric trials, a total of 11 cases of psychosis/mania occurred during 743 person-years of double-blind treatment with these drugs. Hallucinations occurred during doubleblind treatment with every class of compound except Adderall XR, but psychosis/mania events were reported with open-label Adderall XR.
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