Adverse drug reactions related to mood and emotion in pediatric patients treated for attention deficit/hyperactivity disorder: A comparative analysis of the us food and drug administration adverse event reporting system database

Marco Pozzi, Carla Carnovale, Faizan Mazhar, Gabriëlla G.A.M. Peeters, Marta Gentili, Maria Nobile, Sonia Radice, Emilio Clementi

Research output: Contribution to journalArticle

Abstract

Background Attention deficit/hyperactivity disorder (ADHD) can be comorbid with frequent anxiety and mood disorders, as well as emotional symptoms (anxiety, irritability, mood lability). These may also be triggered by drugs and appear as adverse drug reactions (ADRs). Methods We mined data from the US Food and Drug Administration Adverse Event Reporting System pharmacovigilance database, focused on methylphenidate, atomoxetine, amphetamine, lisdexamfetamine, and their derivatives. We collected reports of ADRs connected with mood or emotional symptoms in pediatric patients, excluding drug abuse/accidents. Reporting odds ratios (RORs) were calculated and compared between drug classes and children/adolescents. Results We collected 6176 ADRs of interest of which 59% occurred in children. Atomoxetine accounted for 50.7% of reports, methylphenidate for 32.5%, lisdexamfetamine for 14.2%, and amphetamine for 2.6%. Irritability, anxiety, obsessive thoughts, depressed mood, and euphoria scored significant RORs for all drugs, overall with an increasing risk from methylphenidate to atomoxetine, lisdexamfetamine, and amphetamine. Apathy regarded mostly atomoxetine, and crying regarded all drugs except methylphenidate. Several age-based differences were found. Notably, affect lability hit only adolescents. All drugs scored significant self-injury RORs, except lisdexamfetamine in adolescents, with an increasing risk from methylphenidate to lisdexamfetamine, atomoxetine, and amphetamine. For suicidality, all drugs had significant RORs in children, and methylphenidate was better than atomoxetine and lisdexamfetamine. In adolescents, only methylphenidate and atomoxetine scored significant RORs. Conclusions We conclude that real-world data from the US Food and Drug Administration Adverse Event Reporting System are consistent with previous evidence from meta-analyses. They support a hierarchy of drug safety for several ADRs (except self-injury/suicidality) with methylphenidate as safest, followed by atomoxetine, lisdexamfetamine, and amphetamine last. Self-injury and suicidality RORs were overall higher in children.

Original languageEnglish
Pages (from-to)386-392
Number of pages7
JournalJournal of Clinical Psychopharmacology
Volume39
Issue number4
DOIs
Publication statusPublished - Jul 1 2019

Keywords

  • ADHD
  • adverse drug reactions
  • data mining
  • emotion
  • mood

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Pharmacology (medical)

Fingerprint Dive into the research topics of 'Adverse drug reactions related to mood and emotion in pediatric patients treated for attention deficit/hyperactivity disorder: A comparative analysis of the us food and drug administration adverse event reporting system database'. Together they form a unique fingerprint.

  • Cite this