The occurrence of adverse drug reactions reported for attention deficit hyperactivity disorder (ADHD) medications in the pediatric population: A qualitative review of empirical studies

Neuropsychiatric Disease and Treatment

Volumn 7, Issue 1, 2011, Pages 729-744

  Aagaard, Lise ^a,b,c   Hansen, Ebba Holme ^a,b,c  

^a UNIVERSITY OF COPENHAGEN   (Denmark)

^b FKL Research Centre for Quality in Medicine Use   (Denmark)

^c Danish Pharmacovigilance Research Project (DANPREP)   (Denmark)

Author keywords

Adverse drug reactions; Attention deficit hyperactivity disorder; Children; Pharmacovigilance

Indexed keywords

AMPHETAMINE; ATOMOXETINE; METHYLPHENIDATE; MODAFINIL; PLACEBO; REBOXETINE;

ABNORMAL BEHAVIOR; ACCIDENTAL INJURY; ADVERSE DRUG REACTION; AGGRESSION; AGITATION; ANOREXIA; ANXIETY; ASTHENIA; ASTHMA; ATTENTION DEFICIT DISORDER; BEHAVIOR; BLOOD PRESSURE; BLUNTED AFFECT; BOY; CONSTIPATION; COUGHING; CRYING; DAYDREAMING; DECREASED APPETITE; DEHYDRATION; DEPRESSION; DIARRHEA; DIZZINESS; DREAMING; DRUG ERUPTION; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG SAFETY; DUODENITIS; DYSPEPSIA; EMOTION; EMOTIONAL DISORDER; ERYTHEMA MULTIFORME; EUPHORIA; EYE DISEASE; EYE REDNESS; EYE TWITCHING; FATIGUE; GASTROENTERITIS; GASTROINTESTINAL PAIN; HABIT; HAPPINESS; HEART PALPITATION; HEART RATE; HUMAN; HYPERKINESIA; HYPERSOMNIA; INFECTION; INFLUENZA; INSOMNIA; IRRITABILITY; LACRIMATION; LYMPHADENOPATHY; MANIA; MENTAL INSTABILITY; MOOD CHANGE; MUSCLE HYPERTONIA; MYDRIASIS; NAUSEA; NERVOUSNESS; NIGHTMARE; NOSE CONGESTION; OPPOSITIONAL BEHAVIOR; OSTEOARTHRITIS; OTITIS MEDIA; PAIN; PALLOR; PEPTIC ULCER; PHARYNGITIS; PRURITUS; PSYCHOSOCIAL WITHDRAWAL; PULSE RATE; RESPIRATORY TRACT INFECTION; RESTLESSNESS; REVIEW; RHINITIS; RHINOPHARYNGITIS; SIDE EFFECT; SINUSITIS; SLEEP DISORDER; SOCIAL ISOLATION; SOMNOLENCE; SORE THROAT; STEVENS JOHNSON SYNDROME; STOMACH PAIN; SUICIDE ATTEMPT; TACHYCARDIA; THIRST; THORAX PAIN; TIC; UNITED STATES; UNUSUALLY HAPPY; UPPER ABDOMINAL PAIN; URINE INCONTINENCE; VOMITING; WEIGHT CHANGE; XEROSTOMIA;

EID: 84856197485     PISSN: 11766328     EISSN: 11782021     Source Type: Journal    
DOI: 10.2147/ndt.s26403     Document Type: Review

References (57)

1. American Academy of Pediatrics. Clinical practice guideline: treatment of the school-aged child with attention-deficit/hyperactivity disorder. Pediatrics. 2001;108(4):1033-1044.
2. European Medicines Agency. Meeting Highlights From the Committee for Medicinal Products for Human Use, 16-19 July 2007. Doc. Ref. EMEA/431407/2007. London: European Medicines Agency; 2007. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/ Press_release/2009/12/WC500017068.pdf. Accessed October 31, 2011.
3. Novartis Pharmaceuticals Corporation, United States Food and Drug Administration. Ritalin®, Ritalin-SR®. East Hanover, New Jersey: Novartis Pharmaceuticals Corporation; 2007. Available from: http:// www.accessdata.fda.gov/drugsatfda_docs/label/2007/010187s069,018029s040,021284s011lbl.pdf. Accessed October 31, 2011.
4. Mosholder AD. Overview of ADHD and its pharmacotherapy. Gaithersburg, MD: United States Food and Drug Administration, Drug Safety and Risk Management Advisory Committee; February 9, 2006. Available from: http://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4202S1_01_FDA-mosholder.ppt. Accessed July 18, 2011.
5. Nutt DJ, Fone K, Asherson P, et al. Evidence-based guidelines for management of attention-deficit/hyperactivity disorder in adolescents and in adults: recommendations from the British Association for Psychopharmacology. J Psychopharmacol. 2007;21(1):10-41.
6. Trip AM, Visser ST, Kalverdijk LJ. Large increase of the use of psychostimulants among youth in The Netherlands between 1996 and 2006. Br J Clin Pharmacol. 2009;67(4):466-468.
7. Schubert I, Köster I, Lehmkuhl G. The changing prevalence of attentiondeficit/ hyperactivity disorder and methylphenidate prescriptions: a study of data from a random sample of insurees of the AOK Health Insurance Company in the German State of Hesse, 2000-2007. Dtsch Arztebl Int. 2010;107(36):615-621.
8. Asheim H, Nilsen KB, Johansen K, et al. Forskvivning av sentralstimulerende legemidler ved AD/HD i Nordland [Prescribing of stimulants for ADHD in Nordland County]. Tidsskr Nor Laegeforen. 2007;127:2360-2362. Article in Norwegian.
9. Zuvekas SH, Vitiello B, Norquist GS. Recent trends in the stimulant medication use among US children. Am J Psychiatry. 2006;163(4):579-585.
10. 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(9):884-893.
11. Aagaard L, Thirstrup S, Hansen EH. Opening the white boxes: the licensing documentation of efficacy and safety of psychotropic medicines for children. Pharmacoepidemiol Drug Saf. 2009;18(5):401-411.
12. Biederman J, Krishnan S, Zhang Y, et al. Efficacy and tolerability of lisdexamfetamine dimesylate (NRP-104) in children with attention-deficit/ hyperactivity disorder: a phase III, multicenter, randomized, double-blind, forced-dose, parallel-group study. Clin Ther. 2007;29(3):450-463.
13. Spencer TJ, Abikoff HB, Connor DF, et al. Efficacy and safety of mixed amphetamine salts extended release (Adderall XR) in the management of oppositional defiant disorder with or without comorbid attentiondeficit/ hyperactivity disorder in school-aged children and adolescents: a 4-week, multicenter, randomized, double-blind, parallel-group, placebo-controlled, forced-dose-escalation study. Clin Ther. 2006;28:402-418.
14. Wigal SB, McGough JJ, McCracken et al. A laboratory school comparison of mixed amphetamine salts extended release (Adderall XR) and atomoxetine (Strattera) in school-aged children with attention deficit/hyperactivity disorder. J Atten Disord. 2005;9(1):275-289.
15. Biederman J, Lopez FA, Boellner SW, et al. A randomized, doubleblind, placebo-controlled, parallel-group study of SLI381 (Adderall XR) in children with attention-deficit/hyperactivity disorder. Pediatrics. 2002;110(2):258-266.
16. Efron D, Jarman F, Barker M. Side effects of methylphenidate and dexamphetamine in children with attention deficit hyperactivity disorder: a double-blind, crossover trial. Pediatrics. 1997;100(4):662-666.
17. Arabgol F, Panaghi L, Hebrani P. Reboxetine versus methylphenidate in treatment of children and adolescents with attention deficit-hyperactivity disorder. Eur Child Adolesc Psychiatry. 2009;18(1):53-59.
18. Findling RL, Bukstein OG, Melmed RD, et al. A randomized, doubleblind, placebo-controlled, parallel-group study of methylphenidate transdermal system in pediatric patients with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2008;69(1):149-159.
19. Newcorn JH, Kratochvil CJ, Allen AJ, et al. Atomoxetine and osmotically released methylphenidate for the treatment of attention deficit hyperactivity disorder: acute comparison and differential response. Am J Psychiatry. 2008;165(6):721-730.
20. Maayan L, Paykina N, Fried J, et al. The open-label treatment of attention-deficit/hyperactivity disorder in 4-and 5-year-old children with beaded methylphenidate. J Child Adolesc Psychopharmacol. 2009;19(2):147-153.
21. Findling R, Quinn D, Hatch SJ, et al. Comparison of the clinical efficacy of twice-daily Ritalin and once-daily Equasym XL with placebo in children with Attention-Deficit/Hyperactivity Disorder. Eur Child Adolesc Psychiatry. 2006;15(8):450-459.
22. Greenhill LL, Muniz R, Ball RR, et al. Efficacy and safety of dexmethylphenidate extended-release capsules in children with attentiondeficit/ hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2006;45(7):817-823.
23. 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(3):476-485.
24. Gau SS, Shen HY, Soong WT, et al. An open-label, randomized, activecontrolled equivalent trial of osmotic release oral system methylphenidate in children with attention-deficit/hyperactivity disorder in Taiwan. J Child Adolesc Psychopharmacol. 2006;16(4):441-455.
25. Silva RR, Muniz R, Pestreich L, et al. Efficacy and duration of effect of extended-release dexmethylphenidate versus placebo in schoolchildren with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2006;16(3):293-251.
26. Kemner JE, Starr HL, Ciccone PE, et al. Outcomes of OROS methylphenidate compared with atomoxetine in children with ADHD: a multicenter, randomized prospective study. Adv Ther. 2005;22(5):498-512.
27. Swanson JM, Wigal SB, Wigal T, et al. A comparison of once-daily extended-release methylphenidate formulations in children with attention-deficit/hyperactivity disorder in the laboratory school (the Comacs Study). Pediatrics. 2004;113(3 Pt 1):e206-e216.
28. Biederman J, Quinn D, Weiss M, et al. Efficacy and safety of Ritalin LA, a new, once daily, extended-release dosage form of methylphenidate, in children with attention deficit hyperactivity disorder. Paediatr Drugs. 2003;5(12):833-841.
29. Kratochvil CJ, Heiligenstein JH, Dittmann R, et al. Atomoxetine and methylphenidate treatment in children with ADHD: a prospective, randomized, open-label trial. J Am Acad Child Adolesc Psychiatry. 2002;41(7):776-784.
30. 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(6):e105.
31. Svanborg P, Thernlund G, Gustafsson PA, et al. Efficacy and safety if atomoxetine as add-on to psychoeducation in the treatment of attention deficit/hyperactivity disorder: a randomized, double-blind, placebocontrolled study in stimulant-naïve Swedish children and adolescents. Eur Child Adolesc Psychiatry. 2009;18(4):240-249.
32. Block SL, Kelsey D, Coury D, et al. Once-daily atomoxetine for treating pediatric attention-deficit/hyperactivity disorder: comparison of morning and evening dosing. Clin Pediatr (Phila). 2009;48(7):723-733.
33. Tamayo JM, Pumariega A, Rothe EM, et al. Latino versus Caucasian response to atomoxetine in attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2008;18(1):44-53.
34. Bangs ME, Emslie GJ, et al, (Atomoxetine ADHD and Comorbid MDD Study Group). Efficacy and safety of atomoxetine in adolescents with attention-deficit/hyperactivity disorder and major depression. J Child Adolesc Psychopharmacol. 2007;17(4):407-420.
35. Geller D, Donnelly C, Lopez F, et al. Atomoxetine treatment for pediatric patients with attention-deficit/hyperactivity disorder with comorbid anxiety disorder. J Am Acad Child Adolesc Psychiatry. 2007;46(9):1119-1127.
36. Gau SF, Huang YS, Soong WT, et al. A randomized, double-blind, placebo-controlled clinical trial on once-daily atomoxetine hydrochloride in Taiwanese children and adolescents with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2007;17:4:447-461.
37. Kratochvil CJ, Vaughan BS, Mayfield-Jorgensen ML, et al. A pilot study of atomoxetine in young children with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2007;17(2):175-185.
38. Prasad S, Harpin V, Poole L, et al. A multi-centre, randomized, openlabel study of atomoxetine compared with standard current therapy in UK children and adolescents with attention-deficit/hyperactivity disorder (ADHD). Curr Med Res Opin. 2007;23(2):379-394.
39. Arnold LE, Aman MG, Cook AM, et al. Atomoxetine for hyperactivity in autism spectrum disorders: placebo-controlled crossover pilot trial. J Am Acad Child Adolesc Psychiatry. 2006;45(10):1196-1205.
40. Newcorn JH, Michelson D, Kratochvil CJ, et al. Low-dose atomoxetine for maintenance treatment of attention-deficit/hyperactivity disorder. Pediatrics. 2006;118(6):e1701-e1706.
41. Escobar R, Soutullo C, San Sebastián J, et al. Atomoxetine safety and efficacy in children with attention deficit/hyperactivity disorder (ADHD): initial phase of 10-week treatment in a relapse prevention study with a Spanish sample. Actas Esp Psiquiatr. 2004;33(1):26-32. Article in Spanish.
42. Allen AJ, Kurlan RM, Gilbert DL, et al. Atomoxetine treatment in children and adolescents with ADHD and comorbid tic disorders. Neurology. 2005;65(12):1941-1949.
43. Kelsey DK, Sumner CR, Casat CD, et al. Once-daily atomoxetine treatment for children with attention-deficit/hyperactivity disorder, including an assessment of evening and morning behavior: a doubleblind, placebo-controlled trial. Pediatrics. 2004;114(1):e1-e8.
44. Biederman J, Heiligenstein JH, Faries DE, et al. Efficacy of atomoxetine versus placebo in school-aged girls with attention-deficit/hyperactivity disorder. Pediatrics. 2002;110(6):e75.
45. Michelson D, Allen AJ, Busner J, et al. Once-daily atomoxetine treatment for children and adolescents with attention deficit hyperactivity disorder: a randomized, placebo-controlled study. Am J Psychiatry. 2002;159(11):1896-1901.
46. Spencer T, Heiligenstein JH, Biederman J, et al. Results from 2 proof-of-concept, placebo-controlled studies of atomoxetine in children with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2002;63(12):1140-1147.
47. Michelson D, Faries D, Wernicke J, et al. Atomoxetine in the treatment of children and adolescents with attention-deficit/hyperactivity disorder: a randomized, placebo-controlled, dose-response study. Pediatrics. 2001;108(5):e83.
48. Kahbazi M, Ghoreishi A, Rahiminejad F, et al. A randomized, doubleblind and placebo-controlled trial of modafinil in children and adolescents with attention deficit and hyperactivity disorder. Psychiatry Res. 2009;168(3):234-237.
49. Amiri S, Mohammadi MR, Mohamaddi M, et al. Modafinil as treatment for Attention-Deficit/Hyperactivity Disorder in children and adolescents: a double blind, randomized clinical trial. Prog Neuropsychopharmacol Biol Psychiatry. 2008;32(1):145-149.
50. Boellner S, Earl CQ, Arora S. Modafinil in children and adolescents with attention-deficit/hyperactivity disorder: a preliminary 8-week, open-label study. Curr Med Res Opin. 2006;22(12):2457-2465.
51. Wigal SB, Biederman J, Swanson JM, et al. Efficacy and safety of modafinil film-coated tablets in children and adolescents with or without prior stimulant treatment for attention-deficit/hyperactivity disorder: pooled analysis of 3 randomized, double-blind, placebo-controlled studies. Prim Care Companion J Clin Psychiatry. 2006;8(6):352-360.
52. Biederman J, Swanson JM, Wigal SB, et al. A comparison of once-daily and divided doses of modafinil in children with attention-deficit/hyperactivity disorder: a randomized, double-blind, and placebo-controlled study. J Clin Psychiatry. 2006;67(5):727-735.
53. Greenhill LL, Biederman J, Boellner SW, et al. A randomized, doubleblind, placebo-controlled study of modafinil film-coated tablets in children and adolescents with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2006;45(5):503-511.
54. Biederman J, Swanson JM, Wigal SB, et al. Efficacy and safety of modafinil film-coated tablets in children and adolescents with attention-deficit/hyperactivity disorder: results of a randomized, double-blind, placebo-controlled, flexible-dose study. Pediatrics. 2005;116(6):e777-e784.
55. Hansen EH. Technology assessment in a user perspective-experiences with drug technology. Int J Technol Assess Health Care. 1992;8(1):150-165.
56. Gøtzsche P, Hróbjartsson A, Johansen HK, et al. Constraints on publication rights in industry-initiated clinical trials. JAMA. 2006;295(14):1645-1646.
57. Aagaard L, Hansen EH. Information about ADRs explored by pharmacovigilance approaches: a qualitative review of studies on antibiotics, SSRIs, and NSAIDs. BMC Clin Pharmacol. 2009;9:4.