title: Safety of attention-deficit/hyperactivity disorder medications in children: an intensive pharmacosurveillance monitoring study.
abstract: OBJECTIVE
  Our intensive pharmacosurveillance monitoring program was performed to increase the number of adverse drug reactions (ADRs) recorded in the Italian spontaneous reporting database, and to systematically collect more thorough data about atomoxetine (ATX) and methylphenidate (MPH) safety in the pediatric setting.
  
  
  METHODS
  From September 2007 to October 2010, 1841 youth were enrolled in the Italian Attention- Deficit/Hyperactivity Disorder Register, but we report here on the 76 children from the five Reference Prescription Centers in Campania, an Italian region where we administered our systematic adverse event checklist.
  
  
  RESULTS
  Among our cohort, 68 children received a prescription of ATX and 8 received a prescription of MPH. Most children were male and between 10 and 13 years of age, had a diagnosis of attention-deficit/hyperactivity disorder-combined (ADHD-C) and had learning disability as the main comorbidity. Most ADRs reported to the Italian spontaneous reporting database occurred in patients from Campania. Twenty-five experienced at least 1 ADR for a total of 40 ADRs reported to the Italian drug agency. Most ADRs were common and not serious, and resolved completely. Weight loss was the most frequently reported ADR. Only two ADRs were unexpected and only one was uncommon. Sixteen ADRs resulted in permanent drug withdrawal. Based on the Naranjo algorithm, 25 ADRs were considered "probable" and 15 were considered "possible."
  
  
  CONCLUSIONS
  Although our data provide reassurance of the safety of ATX and MPH, several unexpected or uncommon ADRs (hepatomegaly, suicidal ideation, weight gain, or drug interactions) were identified by our intensive pharmacosurveillance monitoring program. Our results show that an intensive pharmacosurveillance monitoring program that involves pharmacovigilance centers and clinicians can improve the collection of information on drug safety in children.
authors.affiliation: Department of Experimental Medicine, Section of Pharmacology Leonardo Donatelli, Center of Pharmacosurveillance and Pharmacoepidemiology, Faculty of Medicine and Surgery, Second University of Naples, Naples, Italy. simona.ruggiero@unina2.it
authors.forename: Simona
authors.initials: S
authors.lastname: Ruggiero
authors.forename: Concetta
authors.initials: C
authors.lastname: Rafaniello
authors.forename: Carmela
authors.initials: C
authors.lastname: Bravaccio
authors.forename: Giampina
authors.initials: G
authors.lastname: Grimaldi
authors.forename: Rosario
authors.initials: R
authors.lastname: Granato
authors.forename: Antonio
authors.initials: A
authors.lastname: Pascotto
authors.forename: Liberata
authors.initials: L
authors.lastname: Sportiello
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Parretta
authors.forename: Barbara
authors.initials: B
authors.lastname: Rinaldi
authors.forename: Pietro
authors.initials: P
authors.lastname: Panei
authors.forename: Francesco
authors.initials: F
authors.lastname: Rossi
authors.forename: Annalisa
authors.initials: A
authors.lastname: Capuano
mesh_terms: D000293:Adolescent; D018759:Adrenergic Uptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data; D000069445:Atomoxetine Hydrochloride; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000009:adverse effects / Q000627:therapeutic use; D002648:Child; D016208:Databases, Factual; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D008774:Methylphenidate / Q000009:adverse effects* / Q000627:therapeutic use; D060735:Pharmacovigilance; D011437:Propylamines / Q000009:adverse effects* / Q000627:therapeutic use; D012042:Registries
chemical_list: D018759:Adrenergic Uptake Inhibitors; D000697:Central Nervous System Stimulants; D011437:Propylamines; D008774:Methylphenidate; D000069445:Atomoxetine Hydrochloride