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Treatment-emergent psychotic or manic symptoms, eg, hallucinations, delusional thinking, or mania in children and adolescents without a prior history of psychotic illness or mania can be caused by STRATTERA (atomoxetine) at usual doses. If such symptoms occur, consideration should be given to a possible causal role of STRATTERA, and discontinuation of treatment should be considered. In a pooled analysis of multiple short-term, placebo-controlled studies, such symptoms occurred in about 0.2% (4 patients with reactions out of 1939 exposed to STRATTERA for several weeks at usual doses) of STRATTERA-treated patients compared to 0 out of 1056 placebo-treated patients (Strattera Package Insert, 2015).
Pooled Analysis of Pediatric Data (Mosholder, 2009)
The US Food and Drug Administration (FDA) Office of Surveillance and Epidemiology requested the sponsors of all marketed drugs and drugs under clinical development for ADHD to conduct a search of their clinical trial databases for psychosis- and mania-related treatment-emergent adverse events (TEAEs), among others.
The FDA pooled the data within each drug development program to estimate the rates of TEAEs. The findings are subject to the limitations of such safety analyses, which include potential lack of consistency of ascertainment of adverse events across various trials, the possibility of misclassification of cases, and statistical power limitations imposed by the sample sizes.
The FDA requested a search of the STRATTERA clinical trial database using the following standard terms in order to identify potential psychosis- or mania-related TEAEs: psychotic disorder, paranoia, hallucination (any type including visual, auditory, tactile, mixed, etc), delusion (any type including somatic, persecutory, grandeur, reference), schizophrenia (any type), transient psychosis, acute psychosis, childhood psychosis, schizophreniform disorder, schizoaffective disorder, catatonia, mania, and hypomania. The results were to include TEAEs that occurred during pediatric randomized, controlled clinical trials, or within 48 hours of the end of treatment. Patients with more than 1 event were counted only once.
A total of 4 patients with psychosis- or mania-related TEAEs were identified in the combined analysis of 14 randomized, double-blind STRATTERA studies in children and adolescents. All 4 patients were randomized to STRATTERA treatment.
Due to an absence of TEAEs on placebo, the risk ratio was not calculated.
Exposure in trials was calculated in person-years: STRATTERA 487.5, placebo 256.0.
Further review of the 4 TEAEs showed that 3 of the 4 TEAEs were brief, mild in severity, resolved spontaneously, and did not lead to discontinuation from the respective trials (Data on file).
Published Case Reports
Case reports of psychosis- and mania-related TEAEs temporally associated with STRATTERA have been published in the literature (Steinberg, 1985; Henderson, 2004a; Henderson, 2004b; Tang, 2009; Bahali, 2013; Guney, 2014; Liu, 2014; Peruzzolo, 2014).
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Liu CC, Lan CC, Chen YS. Atomoxetine-induced mania with auditory hallucination in an 8‑year-old boy with attention-deficit/hyperactivity disorder and tic disorder. J Child Adolesc Psychopharmacol. 2014;24(8):466-467.
Mosholder AD, Gelperin K, Hammad TA, et al. Hallucinations and other psychotic symptoms associated with the use of attention-deficit/hyperactivity disorder drugs in children. Pediatrics. 2009;123(2):611-616.
Peruzzolo TL, Tramontina S, Rodrigues RB, et al. Avoiding stimulants may not prevent manic switch: a case report with atomoxetine [letter to the editor]. J Neuropsychiatry Clin Neurosci. 2014;26(4):E30-E31.
Strattera [package insert]. Indianapolis, IN: Eli Lilly and Company; 2015.
Tang CS, Chou WJ, Cheng AT. Atomoxetine hydrochloride-associated transient psychosis in an adolescent with attention-deficit/hyperactivity disorder and mild mental retardation. J Child Adolesc Psychopharmacol. 2009;19(3):319-320.
Date of Last Review: April 10, 2017