Safety of medicines used for ADHD in children: A review of published prospective clinical trials

Archives of Disease in Childhood (Impact Factor: 2.9). 04/2014; 99(9). DOI: 10.1136/archdischild-2013-304170
Source: PubMed


To assess the long-term safety of drugs for attention deficit hyperactivity disorder (ADHD).
A bibliographic search was performed in the MEDLINE, EMBASE and PsycINFO databases for prospective studies evaluating the incidence of adverse events (AEs) in children and adolescents treated for ADHD.
A total of six prospective studies that monitored drug safety during therapy for at least 12 weeks were retrieved. The drugs studied were atomoxetine (two studies, 802 patients), osmotic-controlled released oral methylphenidate formulation (two studies, 512 patients), extended release formulation of mixed amphetamine salts (one study, 568 patients) and transdermal methylphenidate (one study, 326 patients). Heterogeneity was found in the duration of follow-up (ranging between 1 and 4 years) and in the way data were reported.The rate of treatment-related AEs ranged from 58% to 78%, and the rate of discontinuation due to AEs ranged from 8% to 25% of the children.Decreased appetite, insomnia, headache and abdominal pain were the most common AEs observed.Most AEs and cases of discontinuation occurred during the first few months of treatment.
Few studies evaluated the long-term safety of drugs for ADHD. Heterogeneity in follow-up duration and in data reporting made comparing different studies and drugs difficult. A systematic monitoring of long-term safety is needed.

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    • "However, evidence for long-term effectiveness remains elusive up to now (Hinshaw & Arnold, 2015). Therefore, and because of the negative side-effects of pharmacological treatment (Clavenna & Bonati, 2014; Vitiello, 2001), research on the treatment of ADHD in recent years has also focused on further non-pharmacological interventions. Exercise is hypothesized to be an effective additional therapeutic option because of its positive effects on cognition in general (Loprinzia, Herodb, Cardinalc, & Noakes, 2013) and, in particular, on the neurobiological pathologies associated with ADHD (Berwid & Halperin, 2012; Gapin, Labban, & Etnier, 2011). "
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    ABSTRACT: Exercise has attracted attention as a potential helpful intervention in children with ADHD. Effects are emphasized on cognition, social-emotional, and motor development. A systematic literature search was conducted using the electronic databases Web of Science, PubMed, Scopus, and ERIC to analyze the efficacy of different types of exercise interventions in children and adolescents with ADHD. Seven studies examining the acute and 14 studies examining the long-term effects were included. The largest effects were reported for mixed exercise programs on ADHD symptomatology and fine motor precision. However, because of the large differences in the study designs, the comparability is limited. At that time, no evidence-based recommendation can be formulated regarding frequency, intensity, or duration of exercise. Nevertheless, some first trends regarding the effects of certain types of exercise can be identified. When focusing on long-term health benefits in children and adolescents with ADHD, qualitative exercise characteristics might play an important role. © 2015 SAGE Publications.
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    ABSTRACT: Attention-deficit hyperactivity disorder is a frequent condition in children and often extends into adulthood. Use of immediate-release methylphenidate (MPH) has raised concerns about potential cardiovascular adverse effects within a few hours after administration. This study was carried out to investigate acute effects of MPH on electrocardiogram (ECG) in a pediatric population. A total of 54 consecutive patients with attention-deficit hyperactivity disorder (51 males and 3 females; mean age =12.14±2.6 years, range 6-19 years), receiving a new prescription of MPH, underwent a standard ECG 2 hours before and after the administration of MPH 10 mg per os. Basal and posttreatment ECG parameters, including mean QT (QT interval when corrected for heart rate [QTc]), QTc dispersion (QTd) interval duration, T-peak to T-end (TpTe) intervals, and TpTe/QT ratio were compared. Significant modifications of both QTc and QTd values were not found after drug administration. QTd fluctuated slightly from 25.7±9.3 milliseconds to 25.1±8.4 milliseconds; QTc varied from 407.6±12.4 milliseconds to 409.8±12.7 milliseconds. A significant variation in blood pressure (systolic blood pressure 105.4±10.3 vs 109.6±11.5; P<0.05; diastolic blood pressure 59.2±7.1 vs 63.1±7.9; P<0.05) was observed, but all the data were within normal range. Heart rate moved from 80.5±15.5 bpm to 87.7±18.8 bpm. No change in TpTe values was found, but a statistically significant increase in TpTe/QTc intervals was found with respect to basal values (0.207±0.02 milliseconds vs 0.214±0.02 milliseconds; P<0.01). The findings of this study show no significant changes in ECG parameters. TpTe values can be an additional parameter to evaluate borderline cases.
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