Pediatric pharmacoepidemiology - safety and effectiveness of medicines for ADHD

References

• American Psychiatric Association. Diagnostic and statistical manual of mental disorders: DSM-5. 5th ed. Washington (DC): American Psychiatric Publishing; 2013.
   Google Scholar
• Polanczyk GV, Salum GA, Sugaya LS, et al. Annual research review: a meta-analysis of the worldwide prevalence of mental disorders in children and adolescents. J Child Psychol Psychiatry. 2015;56:345–365.
   PubMed Web of Science ®Google Scholar
• Thomas R, Sanders S, Doust J, et al. Prevalence of attention-deficit/hyperactivity disorder: a systematic review and meta-analysis. Pediatrics. 2015;135:e994-1001.
   Web of Science ®Google Scholar
• American Academy of Pediatrics. ADHD: clinical practice guideline for the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder in children and adolescents. Pediatrics. 2011;128:1007–1022.
   PubMed Web of Science ®Google Scholar
• National Collaborating Centre For Mental Health. Attention deficit hyperactivity disorder: diagnosis and management of ADHD in children, young people and adults. London: NICE; 2008.
   Google Scholar
• Becker SP, Luebbe AM, Langberg JM. Co-occurring mental health problems and peer functioning among youth with attention-deficit/hyperactivity disorder: a review and recommendations for future research. Clin Child Fam Psychol Rev. 2012;15:279–302.
   PubMed Web of Science ®Google Scholar
• Chen MH, Su TP, Chen YS, et al. Asthma and attention-deficit/hyperactivity disorder: a nationwide population-based prospective cohort study. J Child Psychol Psychiatry. 2013;54:1208–1214.
   PubMed Web of Science ®Google Scholar
• Elia J, Ambrosini P, Berrettini W. ADHD characteristics: I. Concurrent co-morbidity patterns in children & adolescents. Child Adolesc Psychiatry Ment Health. 2008;2:15.
   PubMedGoogle Scholar
• Reale L, Bartoli B, Cartabia M, et al. Comorbidity prevalence and treatment outcome in children and adolescents with ADHD. Eur Child Adolesc Psychiatry. 2017 May 19.
   PubMedGoogle Scholar
• Gillberg C, Gillberg IC, Rasmussen P, et al. Co-existing disorders in ADHD – implications for diagnosis and intervention. Eur Child Adolesc Psychiatry. 2004;13(Suppl 1):I80–I92.
   PubMedGoogle Scholar
• Simpson HA, Jung L, Murphy TK. Update on attention-deficit/hyperactivity disorder and tic disorders: a review of the current literature. Curr Psychiatry Rep. 2011;13:351–356.
   PubMed Web of Science ®Google Scholar
• Vaughan B, Kratochvil CJ. Pharmacotherapy of pediatric attention-deficit/hyperactivity disorder. Child Adolesc Psychiatr Clin N Am. 2012;21:941–955.
   PubMed Web of Science ®Google Scholar
• Aagaard L, Hansen EH. The occurrence of adverse drug reactions reported for attention deficit hyperactivity disorder (ADHD) medications in the pediatric population: a qualitative review of empirical studies. Neuropsychiatr Dis Treat. 2011;7:729–744.
   PubMed Web of Science ®Google Scholar
• Cortese S, Holtmann M, Banaschewski T, et al. Practitioner review: current best practice in the management of adverse events during treatment with ADHD medications in children and adolescents. J Child Psychol Psychiatry. 2013;54:227–246.
   PubMed Web of Science ®Google Scholar
• Graham J, Coghill D. Adverse effects of pharmacotherapies for attention-deficit hyperactivity disorder: epidemiology, prevention and management. CNS Drugs. 2008;22:213–237.
   PubMed Web of Science ®Google Scholar
• Graham J, Banaschewski T, Buitelaar J, et al. European guidelines on managing adverse effects of medication for ADHD. Eur Child Adolesc Psychiatry. 2011;20:17–37.
   PubMed Web of Science ®Google Scholar
• Aagaard L, Hansen EH. Adverse drug reactions from psychotropic medicines in the paediatric population: analysis of reports to the Danish Medicines Agency over a decade. BMC Res Notes. 2010;3:176.
   PubMedGoogle Scholar
• Cheng JY, Chen RY, Ko JS, et al. Efficacy and safety of atomoxetine for attention-deficit/hyperactivity disorder in children and adolescents-meta-analysis and meta-regression analysis. Psychopharmacology (Berl). 2007;194:197–209.
   PubMed Web of Science ®Google Scholar
• Hirota T, Schwartz S, Correll CU. Alpha-2 agonists for attention-deficit/hyperactivity disorder in youth: a systematic review and meta-analysis of monotherapy and add-on trials to stimulant therapy. J Am Acad Child Adolesc Psychiatry. 2014;53:153–173.
   PubMed Web of Science ®Google Scholar
• Ruggiero S, Clavenna A, Reale L, et al. Guanfacine for attention deficit and hyperactivity disorder in pediatrics: a systematic review and meta-analysis. Eur Neuropsychopharmacol. 2014;24:1578–1590.
   PubMed Web of Science ®Google Scholar
• Schachter HM, Pham B, King J, et al. How efficacious and safe is short-acting methylphenidate for the treatment of attention-deficit disorder in children and adolescents? A meta-analysis. Cmaj. 2001;165:1475–1488.
   PubMed Web of Science ®Google Scholar
• Schwartz S, Correll CU. Efficacy and safety of atomoxetine in children and adolescents with attention-deficit/hyperactivity disorder: results from a comprehensive meta-analysis and metaregression. J Am Acad Child Adolesc Psychiatry. 2014;53:174–187.
   PubMed Web of Science ®Google Scholar
• Coghill DR, Caballero B, Sorooshian S, et al. A systematic review of the safety of lisdexamfetamine dimesylate. CNS Drugs. 2014;28:497–511.
   PubMed Web of Science ®Google Scholar
• Clavenna A, Bonati M Safety of medicines used for ADHD in children: a review of published prospective clinical trials. Arch Dis Child. 2014;99:866–872.
   Google Scholar
• Gould MS, Walsh BT, Munfakh JL, et al. Sudden death and use of stimulant medications in youths. Am J Psychiatry. 2009;166:992–1001.
   PubMed Web of Science ®Google Scholar
• Winterstein AG. Cardiovascular safety of stimulants in children: findings from recent population-based cohort studies. Curr Psychiatry Rep. 2013;15:379.
   PubMed Web of Science ®Google Scholar
• Habel LA, Cooper WO, Sox CM, et al. ADHD medications and risk of serious cardiovascular events in young and middle-aged adults. Jama. 2011;306:2673–2683.
   PubMed Web of Science ®Google Scholar
• Dalsgaard S, Kvist AP, Leckman JF, et al. Cardiovascular safety of stimulants in children with attention-deficit/hyperactivity disorder: a nationwide prospective cohort study. J Child Adolesc Psychopharmacol. 2014;24:302–310.
   PubMed Web of Science ®Google Scholar
• Hammerness PG, Karampahtsis C, Babalola R, et al. Attention-deficit/hyperactivity disorder treatment: what are the long-term cardiovascular risks? Expert Opin Drug Saf. 2015;14:543-51.
   PubMed Web of Science ®Google Scholar
• Hammerness PG, Perrin JM, Shelley-Abrahamson R, et al. Cardiovascular risk of stimulant treatment in pediatric attention-deficit/hyperactivity disorder: update and clinical recommendations. J Am Acad Adolesc Psychiatry. 2011;50:978–990.
   PubMed Web of Science ®Google Scholar
• Wernicke JF, Faries D, Girod D, et al. Cardiovascular effects of atomoxetine in children, adolescents, and adults. Drug Saf. 2003;26:729–740.
   PubMed Web of Science ®Google Scholar
• Sayer GR, McGough JJ, Levitt J, et al. Acute and long-term cardiovascular effects of stimulant, guanfacine, and combination therapy for attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2016;26:882–888.
   PubMed Web of Science ®Google Scholar
• Lamberti M, Italiano D, Guerriero L, et al. Evaluation of acute cardiovascular effects of immediate-release methylphenidate in children and adolescents with attention-deficit hyperactivity disorder. Neuropsychiatr Dis Treat. 2015;11:1169–1174.
   PubMed Web of Science ®Google Scholar
• Buchhorn R, Christian W. Ventricular arrhythmias in children with attention deficit disorder–a symptom of autonomic imbalance? Cardiol Young. 2014;24:120–125.
   PubMed Web of Science ®Google Scholar
• Rohatgi RK, Bos JM, Ackerman MJ. Stimulant therapy in children with attention-deficit/hyperactivity disorder and concomitant long QT syndrome: a safe combination? Heart Rhythm. 2015;12:1807–1812.
   PubMed Web of Science ®Google Scholar
• Zhang C, Kutyifa V, Moss AJ, et al. Long-QT syndrome and therapy for attention deficit/hyperactivity disorder. J Cardiovasc Electrophysiol. 2015;26:1039–1044.
   PubMed Web of Science ®Google Scholar
• Dura-Trave T, Yoldi-Petri ME, Gallinas-Victoriano F, et al. Effects of osmotic-release methylphenidate on height and weight in children with attention-deficit hyperactivity disorder (ADHD) following up to four years of treatment. J Child Neurol. 2012;27:604–609.
   PubMed Web of Science ®Google Scholar
• Germinario EA, Arcieri R, Bonati M, et al. Attention-deficit/hyperactivity disorder drugs and growth: an Italian prospective observational study. J Child Adolesc Psychopharmacol. 2013;23:440–447.
   PubMed Web of Science ®Google Scholar
• Harstad EB, Weaver AL, Katusic SK, et al. ADHD, stimulant treatment, and growth: a longitudinal study. Pediatrics. 2014;134:e935–e944.
   PubMed Web of Science ®Google Scholar
• Kim HW, Kim SO, Shon S, et al. Effect of methylphenidate on height and weight in Korean children and adolescents with attention-deficit/hyperactivity disorder: a retrospective chart review. J Child Adolesc Psychopharmacol. 2014;24:448–453.
   PubMed Web of Science ®Google Scholar
• Poulton AS, Melzer E, Tait PR, et al. Growth and pubertal development of adolescent boys on stimulant medication for attention deficit hyperactivity disorder. Med J Aust. 2013;198:29–32.
   PubMed Web of Science ®Google Scholar
• Poulton AS, Bui Q, Melzer E, et al. Stimulant medication effects on growth and bone age in children with attention-deficit/hyperactivity disorder: a prospective cohort study. Int Clin Psychopharmacol. 2016;31:93–99.
   PubMed Web of Science ®Google Scholar
• Schwartz BS, Bailey-Davis L, Bandeen-Roche K, et al. Attention deficit disorder, stimulant use, and childhood body mass index trajectory. Pediatrics. 2014;133:668–676.
   PubMed Web of Science ®Google Scholar
• Faraone SV, Biederman J, Morley CP, et al. Effect of stimulants on height and weight: a review of the literature. J Am Acad Child Adolesc Psychiatry. 2008;47:994–1009.
   PubMed Web of Science ®Google Scholar
• Biederman J, Spencer TJ, Monuteaux MC, et al. A naturalistic 10-year prospective study of height and weight in children with attention-deficit hyperactivity disorder grown up: sex and treatment effects. J Pediatr. 2010;157(635–40):640.
   Google Scholar
• Swanson JM, Arnold LE, Molina BSG, et al. Young adult outcomes in the follow-up of the multimodal treatment study of attention-deficit/hyperactivity disorder: symptom persistence, source discrepancy, and height suppression. J Child Psychol Psychiatry. 2017;58:663–678.
   PubMed Web of Science ®Google Scholar
• Kratochvil CJ, Wilens TE, Greenhill LL, et al. Effects of long-term atomoxetine treatment for young children with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2006;45:919–927.
   PubMed Web of Science ®Google Scholar
• Cohen-Zion M, Ancoli-Israel S. Sleep in children with attention-deficit hyperactivity disorder (ADHD): a review of naturalistic and stimulant intervention studies. Sleep Med Rev. 2004;8:379–402.
   PubMed Web of Science ®Google Scholar
• Cortese S, Faraone SV, Konofal E, et al. Sleep in children with attention-deficit/hyperactivity disorder: meta-analysis of subjective and objective studies. J Am Acad Child Adolesc Psychiatry. 2009;48:894–908.
   PubMed Web of Science ®Google Scholar
• Stein MA, Weiss M, Hlavaty L. ADHD treatments, sleep, and sleep problems: complex associations. Neurotherapeutics. 2012;9:509–517.
   PubMed Web of Science ®Google Scholar
• De Crescenzo F, Armando M, Mazzone L, et al. The use of actigraphy in the monitoring of methylphenidate versus placebo in ADHD: a meta-analysis. Atten Defic Hyperact Disord. 2014;6:49–58.
   PubMedGoogle Scholar
• Bloch MH, Panza KE, Landeros-Weisenberger A, et al. Meta-analysis: treatment of attention-deficit/hyperactivity disorder in children with comorbid tic disorders. J Am Acad Child Adolesc Psychiatry. 2009;48:884–893.
   PubMed Web of Science ®Google Scholar
• Impey M, Heun R. Completed suicide, ideation and attempt in attention deficit hyperactivity disorder. Acta Psychiatr Scand. 2012;125:93–102.
   PubMed Web of Science ®Google Scholar
• Bangs ME, Tauscher-Wisniewski S, Polzer J, et al. Meta-analysis of suicide-related behavior events in patients treated with atomoxetine. J Am Acad Child Adolesc Psychiatry. 2008;47:209–218.
   PubMed Web of Science ®Google Scholar
• Bangs ME, Wietecha LA, Wang S, et al. Meta-analysis of suicide-related behavior or ideation in child, adolescent, and adult patients treated with atomoxetine. J Child Adolesc Psychopharmacol. 2014;24:426–434.
   PubMed Web of Science ®Google Scholar
• Capuano A, Scavone C, Rafaniello C, et al. Atomoxetine in the treatment of attention deficit hyperactivity disorder and suicidal ideation. Expert Opin Drug Saf. 2014;13(Suppl 1):S69–S78.
   PubMed Web of Science ®Google Scholar
• Chen Q, Sjolander A, Runeson B, et al. Drug treatment for attention-deficit/hyperactivity disorder and suicidal behaviour: register based study. Bmj. 2014;348:g3769.
   PubMed Web of Science ®Google Scholar
• Davies M, Coughtrie A, Layton D, et al. Use of atomoxetine and suicidal ideation in children and adolescents: results of an observational cohort study within general practice in England. Eur Psychiatry. 2017;39:11–16.
   PubMed Web of Science ®Google Scholar
• Hesdorffer DC, Ludvigsson P, Olafsson E, et al. ADHD as a risk factor for incident unprovoked seizures and epilepsy in children. Arch Gen Psychiatry. 2004;61:731–736.
   PubMed Web of Science ®Google Scholar
• Dunn DW, Austin JK, Perkins SM. Prevalence of psychopathology in childhood epilepsy: categorical and dimensional measures. Dev Med Child Neurol. 2009;51:364–372.
   PubMed Web of Science ®Google Scholar
• McAfee AT, Holdridge KC, Johannes CB, et al. The effect of pharmacotherapy for attention deficit hyperactivity disorder on risk of seizures in pediatric patients as assessed in an insurance claims database. Curr Drug Saf. 2008;3:123–131.
   PubMedGoogle Scholar
• McAfee AT, Landon J, Jones M, et al. A cohort study of the risk of seizures in a pediatric population treated with atomoxetine or stimulant medications. Pharmacoepidemiol Drug Saf. 2013;22:386–393.
   PubMed Web of Science ®Google Scholar
• 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;123:611–616.
   PubMed Web of Science ®Google Scholar
• Shyu YC, Yuan SS, Lee SY, et al. Attention-deficit/hyperactivity disorder, methylphenidate use and the risk of developing schizophrenia spectrum disorders: a nationwide population-based study in Taiwan. Schizophr Res. 2015;168:161–167.
   PubMed Web of Science ®Google Scholar
• Zulauf CA, Sprich SE, Safren SA, et al. The complicated relationship between attention deficit/hyperactivity disorder and substance use disorders. Curr Psychiatry Rep. 2014;16:436.
   PubMed Web of Science ®Google Scholar
• Humphreys KL, Eng T, Lee SS. Stimulant medication and substance use outcomes: a meta-analysis. JAMA Psychiatry. 2013;70:740–749.
   PubMed Web of Science ®Google Scholar
• Wilens TE, Faraone SV, Biederman J, et al. Does stimulant therapy of attention-deficit/hyperactivity disorder beget later substance abuse? A meta-analytic review of the literature. Pediatrics. 2003;111:179–185.
   PubMed Web of Science ®Google Scholar
• Groenman AP, Oosterlaan J, Rommelse NN, et al. Stimulant treatment for attention-deficit hyperactivity disorder and risk of developing substance use disorder. Br J Psychiatry. 2013;203:112–119.
   PubMed Web of Science ®Google Scholar
• Hammerness P, Joshi G, Doyle R, et al. Do stimulants reduce the risk for cigarette smoking in youth with attention-deficit hyperactivity disorder? A prospective, long-term, open-label study of extended-release methylphenidate. J Pediatr. 2013;162:22–27e2.
   PubMed Web of Science ®Google Scholar
• Molina BS, Hinshaw SP, Eugene AL, et al. Adolescent substance use in the multimodal treatment study of attention-deficit/hyperactivity disorder (ADHD) (MTA) as a function of childhood ADHD, random assignment to childhood treatments, and subsequent medication. J Am Acad Child Adolesc Psychiatry. 2013;52:250–263.
   PubMed Web of Science ®Google Scholar
• Wilens TE, Gignac M, Swezey A, et al. Characteristics of adolescents and young adults with ADHD who divert or misuse their prescribed medications. J Am Acad Child Adolesc Psychiatry. 2006;45:408–414.
   PubMed Web of Science ®Google Scholar
• Donnelly C, Bangs M, Trzepacz P, et al. Safety and tolerability of atomoxetine over 3 to 4 years in children and adolescents with ADHD. J Am Acad Child Adolesc Psychiatry. 2009;48:176–185.
   PubMed Web of Science ®Google Scholar
• Findling RL, Wigal SB, Bukstein OG, et al. Long-term tolerability of the methylphenidate transdermal system in pediatric attention-deficit/hyperactivity disorder: a multicenter, prospective, 12-month, open-label, uncontrolled, phase III extension of four clinical trials. Clin Ther. 2009;31:1844–1855.
   PubMed Web of Science ®Google Scholar
• Harfterkamp M, Buitelaar JK, Minderaa RB, et al. Long-term treatment with atomoxetine for attention-deficit/hyperactivity disorder symptoms in children and adolescents with autism spectrum disorder: an open-label extension study. J Child Adolesc Psychopharmacol. 2013;23:194–199.
   PubMed Web of Science ®Google Scholar
• Hoare P, Remschmidt H, Medori R, et al. 12-month efficacy and safety of OROS MPH in children and adolescents with attention-deficit/hyperactivity disorder switched from MPH. Eur Child Adolesc Psychiatry. 2005;14:305–309.
   PubMed Web of Science ®Google Scholar
• McGough JJ, Biederman J, Wigal SB, et al. Long-term tolerability and effectiveness of once-daily mixed amphetamine salts (Adderall XR) in children with ADHD. J Am Acad Child Adolesc Psychiatry. 2005;44:530–538.
   PubMed Web of Science ®Google Scholar
• Wilens T, McBurnett K, Stein M, et al. ADHD treatment with once-daily OROS methylphenidate: final results from a long-term open-label study. J Am Acad Child Adolesc Psychiatry. 2005;44:1015–1023.
   PubMed Web of Science ®Google Scholar
• Findling RL, Cutler AJ, Saylor K, et al. A long-term open-label safety and effectiveness trial of lisdexamfetamine dimesylate in adolescents with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2013;23:11–21.
   PubMed Web of Science ®Google Scholar
• Thapar A, Cooper M. Attention deficit hyperactivity disorder. Lancet. 2016;387:1240–1250.
   PubMed Web of Science ®Google Scholar
• Kennedy-Martin T, Curtis S, Faries D, et al. A literature review on the representativeness of randomized controlled trial samples and implications for the external validity of trial results. Trials. 2015;16:495.
   PubMed Web of Science ®Google Scholar
• Coghill D, Seth S. Effective management of attention-deficit/hyperactivity disorder (ADHD) through structured re-assessment: the Dundee ADHD Clinical Care Pathway. Child Adolesc Psychiatry Ment Health. 2015;9:52.
   PubMed Web of Science ®Google Scholar
• Christakis DA. Rethinking Attention-Deficit/Hyperactivity Disorder. JAMA Pediatr. 2016;170:109–110.
   PubMed Web of Science ®Google Scholar
• Sudre G, Choudhuri S, Szekely E, et al. Estimating the heritability of structural and functional brain connectivity in families affected by attention-deficit/hyperactivity disorder. JAMA Psychiatry. 2017;74:76–84.
   PubMed Web of Science ®Google Scholar
• Kim JI, Kim JW, Park JE, et al. Association of the GRIN2B rs2284411 polymorphism with methylphenidate response in attention-deficit/hyperactivity disorder. J Psychopharmacol. 2017;31:1070–1077.
   PubMed Web of Science ®Google Scholar