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.
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: Samuele Cortese; Pietro Panei; Romano Arcieri; Elena A P Germinario; Annalisa Capuano; Lucia Margari; Flavia Chiarotti; Paolo Curatolo Journal: CNS Drugs Date: 2015 Impact factor: 5.749
Authors: Victoria A Reed; Jan K Buitelaar; Ernie Anand; Kathleen Ann Day; Tamás Treuer; Himanshu P Upadhyaya; David R Coghill; Ludmila A Kryzhanovskaya; Nicola C Savill Journal: CNS Drugs Date: 2016-07 Impact factor: 5.749
Authors: Ole Jakob Storebø; Nadia Pedersen; Erica Ramstad; Maja Lærke Kielsholm; Signe Sofie Nielsen; Helle B Krogh; Carlos R Moreira-Maia; Frederik L Magnusson; Mathilde Holmskov; Trine Gerner; Maria Skoog; Susanne Rosendal; Camilla Groth; Donna Gillies; Kirsten Buch Rasmussen; Dorothy Gauci; Morris Zwi; Richard Kirubakaran; Sasja J Håkonsen; Lise Aagaard; Erik Simonsen; Christian Gluud Journal: Cochrane Database Syst Rev Date: 2018-05-09