Ruggiero Simona, Rafaniello Concetta, Bravaccio Carmela, Grimaldi Giampina, Granato Rosario, Pascotto Antonio, Sportiello Liberata, Parretta Elisabetta, Rinaldi Barbara, Panei Pietro, Rossi Francesco, Capuano Annalisa
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.
J Child Adolesc Psychopharmacol. 2012 Dec;22(6):415-22. doi: 10.1089/cap.2012.0003.
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.
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.
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."
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.
开展我们的强化药物监测项目，以增加意大利自发报告数据库中记录的药物不良反应（ADR）数量，并系统收集有关儿科环境中托莫西汀（ATX）和哌甲酯（MPH）安全性的更全面数据。
2007年9月至2010年10月，1841名青少年被纳入意大利注意力缺陷/多动障碍登记册，但我们在此报告来自坎帕尼亚五个参考处方中心的76名儿童的情况，坎帕尼亚是意大利的一个地区，我们在那里实施了系统的不良事件清单。
在我们的队列中，68名儿童接受了ATX处方，8名儿童接受了MPH处方。大多数儿童为男性，年龄在10至13岁之间，被诊断为注意力缺陷/多动障碍合并型（ADHD-C），主要合并症为学习障碍。向意大利自发报告数据库报告的大多数ADR发生在坎帕尼亚的患者中。25人经历了至少1次ADR，总共向意大利药品管理机构报告了40次ADR。大多数ADR常见且不严重，并完全缓解。体重减轻是最常报告的ADR。只有两次ADR是意外的，只有一次是不常见的。16次ADR导致永久停药。根据纳兰霍算法，25次ADR被认为“很可能”，15次被认为“有可能”。
尽管我们的数据表明ATX和MPH的安全性令人放心，但我们的强化药物监测项目识别出了一些意外或不常见的ADR（肝肿大、自杀意念、体重增加或药物相互作用）。我们的结果表明，一个涉及药物警戒中心和临床医生的强化药物监测项目可以改善儿童药物安全性信息的收集。
