Atomoxetine-Induced Hypomania-Like Symptoms in a Preadolescent Patient

Güney, Esra; Üneri, Özden Şükran

doi:10.1089/cap.2013.0112

Cited by 10 publications

(15 citation statements)

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“…We found the evidence for atomoxetine causing aggression/hostility events inconclusive [27,30,38], and psychosis/mania appeared to be mainly in patients with comorbid bipolar disorder or MDD [19,28,[39][40][41][42]. However, it is notable that patients with ADHD often have comorbid psychiatry disorders, including bipolar disorder and MDD [19,106].…”

Section: Discussionmentioning

confidence: 99%

“…There was also a case report of ''hypomania-like symptoms'' in a 10-year-old boy with comorbid anxiety disorder and ADHD who received 10 mg/day atomoxetine with gradual dose increments and attended clinic 7 days after beginning treatment. The hypomania-like symptoms had abated when assessed 5 days after cessation of atomoxetine treatment [42].…”

Section: Findings In the Predefined Literature Searchmentioning

confidence: 96%

“…Using our predefined search strategy, we identified seven studies/case reports of children and adolescents with ADHD who had been assessed for psychosis/mania [17,19,28,[39][40][41][42]. In five of these, the symptoms of psychosis, mania, or hypomania were investigated in patients within the context of a specific comorbid psychiatric condition, i.e., bipolar disorder [39][40][41], major depressive disorder (MDD) [28], and anxiety disorder [42].…”

Section: Findings In the Predefined Literature Searchmentioning

confidence: 99%

“…In five of these, the symptoms of psychosis, mania, or hypomania were investigated in patients within the context of a specific comorbid psychiatric condition, i.e., bipolar disorder [39][40][41], major depressive disorder (MDD) [28], and anxiety disorder [42].…”

Section: Findings In the Predefined Literature Searchmentioning

confidence: 99%

“…Of the other five studies/case reports, all investigating the effects of atomoxetine treatment in patients who had a specific comorbid psychiatric condition, four reported B12 atomoxetine-treated patients with ADHD [39][40][41][42], and three of these concerned comorbid bipolar disorder and ADHD. In one study of comorbid bipolar disorder and ADHD, no manic or mixed episodes were detected after 8 weeks of open-label adjunct atomoxetine treatment (mean final dose was 59.2 mg/day, with a maximum allowed dose of 1.2 mg/kg; N = 12), although two patients discontinued treatment because of worsening mood symptoms [39].…”

Section: Findings In the Predefined Literature Searchmentioning

confidence: 99%

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The Safety of Atomoxetine for the Treatment of Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: A Comprehensive Review of Over a Decade of Research

et al. 2016

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Atomoxetine is a noradrenergic reuptake inhibitor prescribed for attention-deficit/hyperactivity disorder (ADHD) that first gained approval in the USA in 2002 and has been authorized in 97 countries worldwide. The aim of this paper is to comprehensively review publications that addressed one or more of seven major safety topics relevant to atomoxetine treatment of children and adolescents (aged ≥6 years) diagnosed with ADHD. While the review focuses on children and adolescents, publications in which data from patients aged >18 years and from 6 to 18 years were analyzed in the same dataset were included. Using a predefined search strategy, including agreement of two reviewers when selecting papers, reduced the potential for bias. Using this process, we identified 70 eligible papers (clinical trials, epidemiological studies, and case reports) across the seven topics. We also referred to the European Summary of Product Characteristics (SPC) and US label. We found 15 papers about suicidality, three about aggression/hostility, seven about psychosis/mania, six about seizures, seven about hepatic effects, 29 about cardiovascular effects, and 28 about growth and development. The main findings (i.e., those from the largest and most well-conducted studies/analyses) are as follows. A large register-based study of pediatric and adult patients (6818 received atomoxetine) calculated a hazard ratio of 0.96 for suicide-related events during treatment with atomoxetine, and a meta-analysis of 23 placebo-controlled studies (N = 3883), published in 2014, found no completed suicides and no statistically significant association between atomoxetine and suicidality. The frequency of aggression/hostility was not statistically significantly higher with atomoxetine, e.g., experienced by 1.6 % (N = 21/1308) of atomoxetine-treated patients versus 1.1 % (N = 9/806) of placebo-treated patients in one meta-analysis. Symptoms of psychosis and mania were mainly observed in patients with comorbid bipolar disorder/depression. Based on spontaneous reports, during a 2-year period when 2.233 million adult and pediatric patients were exposed to atomoxetine, the reporting rate for seizures was 8 per 100,000 patients. In the manufacturer's database, atomoxetine was a "probable cause" of three hepatic adverse events (AEs) (all reversible hepatitis), and 133 hepatic AEs had possible confounding factors and were "possibly related" to atomoxetine, during 4 years when atomoxetine exposure had reached about 4.3 million patients. Rare cases of severe liver injury are described in the US label and European SPC; a case requiring liver transplantation is described in the US label. In a comprehensive review of a clinical trials database (N = 8417 received atomoxetine), most pediatric patients experienced modest increases in heart rate and blood pressure, and 8-12 % experienced more pronounced changes (≥20 bpm, ≥15 to 20 mmHg). However, in three long-term analyses (≥2 years), blood pressure was within age norms, and few patients discontinued due to cardiovascular AE...

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