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

References

• American Academy of PediatricsClinical practice guideline: treatment of the school-aged child with attention-deficit/hyperactivity disorderPediatrics200110841033104411581465
   PubMed Web of Science ®Google Scholar
• European Medicines AgencyMeeting Highlights From the Committee for Medicinal Products for Human Use, Doc. Ref. EMEA/431407/2007LondonEuropean Medicines Agency2007 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2009/12/WC500017068.pdf16–1972007Accessed October 31, 2011
   Google Scholar
• Novartis Pharmaceuticals Corporation, United States Food and Drug AdministrationRitalin^®, Ritalin-SR^®East Hanover, New JerseyNovartis Pharmaceuticals Corporation2007 Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/010187s069,018029s040,021284s011lbl.pdfAccessed October 31, 2011
   Google Scholar
• MosholderADOverview of ADHD and its pharmacotherapyGaithersburg, MDUnited States Food and Drug Administration, Drug Safety and Risk Management Advisory Committee292006 Available from: http://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4202S1_01_FDA-mosholder.pptAccessed July 18, 2011
   Google Scholar
• NuttDJFoneKAshersonPEvidence-based guidelines for management of attention-deficit/hyperactivity disorder in adolescents and in adults: recommendations from the British Association for PsychopharmacologyJ Psychopharmacol2007211104117092962
   PubMed Web of Science ®Google Scholar
• TripAMVisserSTKalverdijkLJLarge increase of the use of psycho-stimulants among youth in The Netherlands between 1996 and 2006Br J Clin Pharmacol200967446646819371321
   PubMed Web of Science ®Google Scholar
• SchubertIKösterILehmkuhlGThe changing prevalence of attention-deficit/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, 2000–2007Dtsch Arztebl Int20101073661562120948775
   PubMed Web of Science ®Google Scholar
• AsheimHNilsenKBJohansenKForskvivning av sentralstimulerende legemidler ved AD/HD i Nordland [Prescribing of stimulants for ADHD in Nordland County]Tidsskr Nor Laegeforen200712723602362 Article in Norwegian17895938
   PubMedGoogle Scholar
• ZuvekasSHVitielloBNorquistGSRecent trends in the stimulant medication use among US childrenAm J Psychiatry2006163457958516585430
   PubMed Web of Science ®Google Scholar
• BlochMHPanzaKELanderos-WeisenbergerAMeta-analysis: treatment of attention-deficit/hyperactivity disorder in children with comorbid tic disordersJ Am Acad Child Adolesc Psychiatry200948988489319625978
   PubMed Web of Science ®Google Scholar
• AagaardLThirstrupSHansenEHOpening the white boxes: the licensing documentation of efficacy and safety of psychotropic medicines for childrenPharmacoepidemiol Drug Saf200918540141119326364
   PubMed Web of Science ®Google Scholar
• BiedermanJKrishnanSZhangYEfficacy 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 studyClin Ther200729345046317577466
   PubMed Web of Science ®Google Scholar
• SpencerTJAbikoffHBConnorDFEfficacy and safety of mixed amphetamine salts extended release (Adderall XR) in the management of oppositional defiant disorder with or without comorbid attention-deficit/ hyperactivity disorder in school-aged children and adolescents: a 4-week, multicenter, randomized, double-blind, parallel-group, placebo-controlled, forced-dose-escalation studyClin Ther20062840241816750455
   PubMed Web of Science ®Google Scholar
• WigalSBMcGoughJJMcCrackenA laboratory school comparison of mixed amphetamine salts extended release (Adderall XR) and atomoxetine (Strattera) in school-aged children with attention deficit/hyperactivity disorderJ Atten Disord20059127528916371674
   PubMedGoogle Scholar
• BiedermanJLopezFABoellnerSWA randomized, double-blind, placebo-controlled, parallel-group study of SLI381 (Adderall XR) in children with attention-deficit/hyperactivity disorderPediatrics2002110225826612165576
   PubMed Web of Science ®Google Scholar
• EfronDJarmanFBarkerMSide effects of methylphenidate and dexamphetamine in children with attention deficit hyperactivity disorder: a double-blind, crossover trialPediatrics199710046626669310521
   PubMed Web of Science ®Google Scholar
• ArabgolFPanaghiLHebraniPReboxetine versus methylphenidate in treatment of children and adolescents with attention deficit-hyperactivity disorderEur Child Adolesc Psychiatry2009181535918563471
   PubMed Web of Science ®Google Scholar
• FindlingRLBuksteinOGMelmedRDA randomized, double-blind, placebo-controlled, parallel-group study of methylphenidate transdermal system in pediatric patients with attention-deficit/hyperactivity disorderJ Clin Psychiatry200869114915918312050
   PubMed Web of Science ®Google Scholar
• NewcornJHKratochvilCJAllenAJAtomoxetine and osmotically released methylphenidate for the treatment of attention deficit hyperactivity disorder: acute comparison and differential responseAm J Psychiatry2008165672173018281409
   PubMed Web of Science ®Google Scholar
• MaayanLPaykinaNFriedJThe open-label treatment of attention-deficit/hyperactivity disorder in 4- and 5-year-old children with beaded methylphenidateJ Child Adolesc Psychopharmacol200919214715319374023
   PubMed Web of Science ®Google Scholar
• FindlingRQuinnDHatchSJComparison of the clinical efficacy of twice-daily Ritalin and once-daily Equasym XL with placebo in children with Attention-Deficit/Hyperactivity DisorderEur Child Adolesc Psychiatry200615845045916791541
   PubMed Web of Science ®Google Scholar
• GreenhillLLMunizRBallRREfficacy and safety of dexmethylphenidate extended-release capsules in children with attention-deficit/hyperactivity disorderJ Am Acad Child Adolesc Psychiatry200645781782316832318
   PubMed Web of Science ®Google Scholar
• McGoughJJWigalSBAbikoffHA randomized, double-blind, placebo-controlled, laboratory classroom assessment of methylphenidate transdermal system in children with ADHDJ Atten Disord20069347648516481664
   PubMedGoogle Scholar
• GauSSShenHYSoongWTAn open-label, randomized, active-controlled equivalent trial of osmotic release oral system methylphenidate in children with attention-deficit/hyperactivity disorder in TaiwanJ Child Adolesc Psychopharmacol200616444145516958569
   PubMed Web of Science ®Google Scholar
• SilvaRRMunizRPestreichLEfficacy and duration of effect of extended-release dexmethylphenidate versus placebo in school-children with attention-deficit/hyperactivity disorderJ Child Adolesc Psychopharmacol2006163293251
   Web of Science ®Google Scholar
• KemnerJEStarrHLCicconePEOutcomes of OROS methylphenidate compared with atomoxetine in children with ADHD: a multicenter, randomized prospective studyAdv Ther200522549851216418159
   PubMed Web of Science ®Google Scholar
• SwansonJMWigalSBWigalTA comparison of once-daily extended-release methylphenidate formulations in children with attention-deficit/hyperactivity disorder in the laboratory school (the Comacs Study)Pediatrics20041133 Pt 1e206e21614993578
   PubMed Web of Science ®Google Scholar
• BiedermanJQuinnDWeissMEfficacy and safety of Ritalin LA, a new, once daily, extended-release dosage form of methylphenidate, in children with attention deficit hyperactivity disorderPaediatr Drugs200351283384114658924
   PubMedGoogle Scholar
• KratochvilCJHeiligensteinJHDittmannRAtomoxetine and methylphenidate treatment in children with ADHD: a prospective, randomized, open-label trialJ Am Acad Child Adolesc Psychiatry200241777678412108801
   PubMed Web of Science ®Google Scholar
• PelhamWEGnagyEMBurrows-MacleanLOnce-a-day Concerta methylphenidate versus three-times-daily methylphenidate in laboratory and natural settingsPediatrics20011076e10511389303
   PubMed Web of Science ®Google Scholar
• SvanborgPThernlundGGustafssonPAEfficacy and safety if atomoxetine as add-on to psychoeducation in the treatment of attention deficit/hyperactivity disorder: a randomized, double-blind, placebo-controlled study in stimulant-naïve Swedish children and adolescentsEur Child Adolesc Psychiatry200918424024919156355
   PubMed Web of Science ®Google Scholar
• BlockSLKelseyDCouryDOnce-daily atomoxetine for treating pediatric attention-deficit/hyperactivity disorder: comparison of morning and evening dosingClin Pediatr (Phila)200948772373319420182
   PubMed Web of Science ®Google Scholar
• TamayoJMPumariegaARotheEMLatino versus Caucasian response to atomoxetine in attention-deficit/hyperactivity disorderJ Child Adolesc Psychopharmacol2008181445318294088
   PubMed Web of Science ®Google Scholar
• BangsMEEmslieGJAtomoxetine ADHD and Comorbid MDD Study GroupEfficacy and safety of atomoxetine in adolescents with attention-deficit/hyperactivity disorder and major depressionJ Child Adolesc Psychopharmacol200717440742017822337
   PubMed Web of Science ®Google Scholar
• GellerDDonnellyCLopezFAtomoxetine treatment for pediatric patients with attention-deficit/hyperactivity disorder with comorbid anxiety disorderJ Am Acad Child Adolesc Psychiatry20074691119112717712235
   PubMed Web of Science ®Google Scholar
• GauSFHuangYSSoongWTA randomized, double-blind, placebo-controlled clinical trial on once-daily atomoxetine hydrochloride in Taiwanese children and adolescents with attention-deficit/hyperactivity disorderJ Child Adolesc Psychopharmacol200717444746117822340
   PubMed Web of Science ®Google Scholar
• KratochvilCJVaughanBSMayfield-JorgensenMLA pilot study of atomoxetine in young children with attention-deficit/hyperactivity disorderJ Child Adolesc Psychopharmacol200717217518517489712
   PubMed Web of Science ®Google Scholar
• PrasadSHarpinVPooleLA multi-centre, randomized, open-label study of atomoxetine compared with standard current therapy in UK children and adolescents with attention-deficit/hyperactivity disorder (ADHD)Curr Med Res Opin200723237939417288692
   PubMed Web of Science ®Google Scholar
• ArnoldLEAmanMGCookAMAtomoxetine for hyperactivity in autism spectrum disorders: placebo-controlled crossover pilot trialJ Am Acad Child Adolesc Psychiatry200645101196120517003665
   PubMed Web of Science ®Google Scholar
• NewcornJHMichelsonDKratochvilCJLow-dose atomoxetine for maintenance treatment of attention-deficit/hyperactivity disorderPediatrics20061186e1701e170617101710
   PubMed Web of Science ®Google Scholar
• EscobarRSoutulloCSan SebastiánJAtomoxetine 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 sampleActas Esp Psiquiatr20043312632 Article in Spanish15704028
   PubMed Web of Science ®Google Scholar
• AllenAJKurlanRMGilbertDLAtomoxetine treatment in children and adolescents with ADHD and comorbid tic disordersNeurology200565121941194916380617
   PubMed Web of Science ®Google Scholar
• KelseyDKSumnerCRCasatCDOnce-daily atomoxetine treatment for children with attention-deficit/hyperactivity disorder, including an assessment of evening and morning behavior: a double-blind, placebo-controlled trialPediatrics20041141e1e815231966
   PubMed Web of Science ®Google Scholar
• BiedermanJHeiligensteinJHFariesDEEfficacy of atomoxetine versus placebo in school-aged girls with attention-deficit/hyperactivity disorderPediatrics20021106e7512456942
   PubMed Web of Science ®Google Scholar
• MichelsonDAllenAJBusnerJOnce-daily atomoxetine treatment for children and adolescents with attention deficit hyperactivity disorder: a randomized, placebo-controlled studyAm J Psychiatry2002159111896190112411225
   PubMed Web of Science ®Google Scholar
• SpencerTHeiligensteinJHBiedermanJResults from 2 proof-of-concept, placebo-controlled studies of atomoxetine in children with attention-deficit/hyperactivity disorderJ Clin Psychiatry200263121140114712523874
   PubMed Web of Science ®Google Scholar
• MichelsonDFariesDWernickeJAtomoxetine in the treatment of children and adolescents with attention-deficit/hyperactivity disorder: a randomized, placebo-controlled, dose-response studyPediatrics20011085e8311694667
   PubMed Web of Science ®Google Scholar
• KahbaziMGhoreishiARahiminejadFA randomized, double-blind and placebo-controlled trial of modafinil in children and adolescents with attention deficit and hyperactivity disorderPsychiatry Res2009168323423719439364
   PubMed Web of Science ®Google Scholar
• AmiriSMohammadiMRMohamaddiMModafinil as treatment for Attention-Deficit/Hyperactivity Disorder in children and adolescents: a double blind, randomized clinical trialProg Neuropsychopharmacol Biol Psychiatry200832114514917765380
   PubMed Web of Science ®Google Scholar
• BoellnerSEarlCQAroraSModafinil in children and adolescents with attention-deficit/hyperactivity disorder: a preliminary 8-week, open-label studyCurr Med Res Opin200622122457246517257460
   PubMed Web of Science ®Google Scholar
• WigalSBBiedermanJSwansonJMEfficacy 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 studiesPrim Care Companion J Clin Psychiatry20068635236017245457
   PubMedGoogle Scholar
• BiedermanJSwansonJMWigalSBA comparison of once-daily and divided doses of modafinil in children with attention-deficit/hyperactivity disorder: a randomized, double-blind, and placebo-controlled studyJ Clin Psychiatry200667572773516841622
   PubMed Web of Science ®Google Scholar
• GreenhillLLBiedermanJBoellnerSWA randomized, double-blind, placebo-controlled study of modafinil film-coated tablets in children and adolescents with attention-deficit/hyperactivity disorderJ Am Acad Child Adolesc Psychiatry200645550351116601402
   PubMed Web of Science ®Google Scholar
• BiedermanJSwansonJMWigalSBEfficacy 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 studyPediatrics20051166e777e78416322134
   PubMed Web of Science ®Google Scholar
• HansenEHTechnology assessment in a user perspective – experiences with drug technologyInt J Technol Assess Health Care1992811501651601585
   PubMedGoogle Scholar
• GøtzschePHróbjartssonAJohansenHKConstraints on publication rights in industry-initiated clinical trialsJAMA2006295141645164616609085
   PubMed Web of Science ®Google Scholar
• AagaardLHansenEHInformation about ADRs explored by pharmacovigilance approaches: a qualitative review of studies on antibiotics, SSRIs, and NSAIDsBMC Clin Pharmacol20099419254390
   PubMedGoogle Scholar