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

Archives of Disease in Childhood

Volumn 99, Issue 9, 2014, Pages 866-872

  Clavenna, Antonio ^a   Bonati, Maurizio ^a  

^a MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

AMPHETAMINE DERIVATIVE; ATOMOXETINE; METHYLPHENIDATE;

ABDOMINAL PAIN; ABNORMAL THINKING; ANOREXIA; ANXIETY DISORDER; ATTENTION DEFICIT DISORDER; BODY WEIGHT DISORDER; CHILD; CHILDHOOD DISEASE; CLINICAL EVALUATION; CLINICAL TRIAL (TOPIC); DECREASED APPETITE; DEPRESSION; DIARRHEA; DISEASE DURATION; DISEASE EXACERBATION; DIZZINESS; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG WITHDRAWAL; EMBASE; EMOTIONAL DISORDER; FATIGUE; FOLLOW UP; HUMAN; INCIDENCE; INSOMNIA; LOSS OF APPETITE; MEDLINE; MENTAL INSTABILITY; NAUSEA AND VOMITING; PERSONALITY DISORDER; PRIORITY JOURNAL; PROSPECTIVE STUDY; PSYCHOPHARMACOTHERAPY; PSYCINFO; REVIEW; SLEEP DISORDER; SOMNOLENCE; TIC; UPPER ABDOMINAL PAIN;

CHILD PSYCHIATRY; PHARMACOLOGY;

ADOLESCENT; AMPHETAMINES; ATTENTION DEFICIT DISORDER WITH HYPERACTIVITY; CENTRAL NERVOUS SYSTEM STIMULANTS; CHILD; HUMANS; METHYLPHENIDATE; PROPYLAMINES; PROSPECTIVE STUDIES; TREATMENT OUTCOME;

EID: 84906936950     PISSN: 00039888     EISSN: 14682044     Source Type: Journal    
DOI: 10.1136/archdischild-2013-304170     Document Type: Review

References (45)

1. American Psychiatric Association. Task force on DSM-IV. Diagnostic and statistical manual of mental disorders: DSM-IV-TR. 4th edn. Washington, DC: American Psychiatric Association, 2010.
2. 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;128:1007-22.
3. National Collaborating Centre For Mental Health. Attention deficit hyperactivity disorder: diagnosis and management of ADHD in children, young people and adults. London: NICE, 2008.
4. Vaughan B, Kratochvil CJ. Pharmacotherapy of pediatric attention-deficit/hyperactivity disorder. Child Adolesc Psychiatr Clin N Am 2012;21:941-55.
5. 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;54:227-46.
6. 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;7:729-44.
7. Graham J, Coghill D. Adverse effects of pharmacotherapies for attention-deficit hyperactivity disorder: epidemiology, prevention and management. CNS Drugs 2008;22:213-37. (Pubitemid 351263725)
8. 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.
9. 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;165:1475-88. (Pubitemid 34060190)
10. Clavenna A, Bonati M. Adverse drug reactions in childhood: a review of prospective studies and safety alerts. Arch Dis Child 2009;94:724-8.
11. Food and Drug Administration. Methylphenidate ADHD Medications: Drug Safety Communication - Risk of Long-lasting Erections. http://www.fda.gov/ Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm378876. htm?source=govdelivery&utm-medium=email&utm-source=govdelivery
12. 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. (Pubitemid 47457955)
13. Molina BS, Flory K, Hinshaw SP, et al. Delinquent behavior and emerging substance use in the MTA at 36 months: prevalence, course, and treatment effects. J Am Acad Child Adolesc Psychiatry 2007;46:1028-40. (Pubitemid 47220685)
14. Swanson JM, Elliott GR, Greenhill LL, et al. Effects of stimulant medication on growth rates across 3 years in the MTA follow-up. J Am Acad Child Adolesc Psychiatry 2007;46:1015-27. (Pubitemid 47224817)
15. Molina BS, Hinshaw SP, Swanson JM, et al. The MTA at 8 years: prospective follow-up of children treated for combined-type ADHD in a multisite study. J Am Acad Child Adolesc Psychiatry 2009;48:484-500.
16. Barbaresi WJ, Katusic SK, Colligan RC, et al. Long-term stimulant medication treatment of attention-deficit/hyperactivity disorder: results from a population-based study. J Dev Behav Pediatr 2006;27:1-10. (Pubitemid 44315107)
17. Charach A, Ickowicz A, Schachar R. Stimulant treatment over five years: adherence, effectiveness, and adverse effects. J Am Acad Child Adolesc Psychiatry 2004;43:559-67. (Pubitemid 38812367)
18. Didoni A, Sequi M, Panei P, et al. One-year prospective follow-up of pharmacological treatment in children with attention-deficit/hyperactivity disorder. Eur J Clin Pharmacol 2011;67:1061-7.
19. 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;48:176-85.
20. 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;31:1844-55.
21. Grcevich S, Rowane WA, Marcellino B, et al. Retrospective comparison of Adderall and methylphenidate in the treatment of attention deficit hyperactivity disorder. J Child Adolesc Psychopharmacol 2001;11:35-41. (Pubitemid 32295181)
22. 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;23:194-9.
23. 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;14:305-9.
24. Kesic A, Lakic A, Dronjak D, et al. Effects of OROS methylphenidate (OROS MPH) treatment in children and adolescents with ADHD, mental retardation and epilepsy. Eur Neuropsychopharmacol 2012;22:S420-1.
25. Mazzone L, Reale L, Mannino V, et al. Lower IQ is associated with decreased clinical response to atomoxetine in children and adolescents with attention-deficit hyperactivity disorder. CNS Drugs 2011;25:503-9.
26. 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;44:530-8. (Pubitemid 40720952)
27. Nikles CJ, Mitchell GK, Del Mar CB, et al. Long-term changes in management following n-of-1 trials of stimulants in attention-deficit/ hyperactivity disorder. Eur J Clin Pharmacol 2007;63:985-9. (Pubitemid 47561807)
28. Ruggiero S, Rafaniello C, Bravaccio C, et al. Safety of attention-deficit/hyperactivity disorder medications in children: An intensive pharmacosurveillance monitoring study. J Child Adolesc Psychopharmacol 2012;22:415-22.
29. Wilens T, Pelham W, Stein M, et al. ADHD treatment with once-daily OROS methylphenidate: interim 12-month results from a long-term open-label study. J Am Acad Child Adolesc Psychiatry 2003;42:424-33. (Pubitemid 39625077)
30. 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;44:1015-23. (Pubitemid 41377557)
31. Wolff C, Alfred A, Lindermuller A, et al. Effect of transitioning from extended-release methylphenidate onto osmotic, controlled-release methylphenidate in children/adolescents with ADHD: results of a 3-month non-interventional study. Curr Med Res Opin 2011;27(Suppl 2):35-44.
32. Biederman J, Lopez FA, Boellner SW, et al. A randomized, double-blind, placebo-controlled, parallel-group study of SLI381 (Adderall XR) in children with attention-deficit/hyperactivity disorder. Pediatrics 2002;110:258-66. (Pubitemid 34833008)
33. McCracken JT, Biederman J, Greenhill LL, et al. Analog classroom assessment of a once-daily mixed amphetamine formulation, SLI381 (Adderall XR), in children with ADHD. J Am Acad Child Adolesc Psychiatry 2003;42:673-83. (Pubitemid 39625053)
34. Pelham WE, Gnagy EM, Burrows-MacLean L, et al. Once-a-day Concerta methylphenidate versus three-times-daily methylphenidate in laboratory and natural settings. Pediatrics 2001;107:E105.
35. Wolraich ML, Greenhill LL, Pelham W, et al. Randomized, controlled trial of oros methylphenidate once a day in children with attention-deficit/ hyperactivity disorder. Pediatrics 2001;108:883-92. (Pubitemid 32947657)
36. Remschmidt H, Hoare P, Ettrich C, et al. Symptom control in children and adolescents with attention-deficit/hyperactivity disorder on switching from immediate-release MPH to OROS MPH Results of a 3-week open-label study. Eur Child Adolesc Psychiatry 2005;14:297-304.
37. Findling RL, Bukstein OG, Melmed RD, et al. A randomized, double-blind, placebo-controlled, parallel-group study of methylphenidate transdermal system in pediatric patients with attention-deficit/hyperactivity disorder. J Clin Psychiatry 2008;69:149-59. (Pubitemid 351282009)
38. McGough JJ, Wigal SB, Abikoff H, et al. A randomized, double-blind, placebo-controlled, laboratory classroom assessment of methylphenidate transdermal system in children with ADHD. J Atten Disord 2006;9:476-85. (Pubitemid 43171141)
39. Anderson M, Choonara I. A systematic review of safety monitoring and drug toxicity in published randomised controlled trials of antiepileptic drugs in children over a 10-year period. Arch Dis Child 2010;95:731-8.
40. Nor Aripin KN, Choonara I, Sammons HM. Systematic review of safety in paediatric drug trials published in 2007. Eur J Clin Pharmacol 2012;68:189-94.
41. Smith SM, Wang AT, Katz NP, et al. Adverse event assessment, analysis, and reporting in recent published analgesic clinical trials: ACTTION systematic review and recommendations. Pain 2013;154:997-1008.
42. de Vries TW, van Roon EN. Low quality of reporting adverse drug reactions in paediatric randomised controlled trials. Arch Dis Child 2010;95:1023-6.
43. Martinez-Raga J, Knecht C, Szerman N, et al. Risk of serious cardiovascular problems with medications for attention-deficit hyperactivity disorder. CNS Drugs 2013;27:15-30.
44. Westover AN, Halm EA. Do prescription stimulants increase the risk of adverse cardiovascular events? A systematic review. BMC Cardiovasc Disord 2012;12:41.
45. Bonati M, Reale L. Reducing overdiagnosis and disease mongering in ADHD in Lombardy. BMJ 2013;347:f7474.