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Differences between paediatric and adult suspected neuropsychiatric adverse drug reactions of Melatonin reported to the European Medicines Agency
Biotechnology & Biotechnological Equipment ( IF 1.5 ) Pub Date : 2021-06-04 , DOI: 10.1080/13102818.2021.1932595
Dimitar Vaskov Bakalov 1 , Pavlina Andreeva Gateva 2 , Radka Kirilova Tafradjiiska-Hadjiolova 1
Affiliation  

Abstract

Melatonin has been approved as a sleep medication in Europe since 2007. The pharmacological dosages of this substance are much higher than the physiological ones, so it is no surprise that it has potential for many adverse effects. In children melatonin has been used for many years off-label, but in 2018 the Committee for Medicinal Products for Human Use (CHMP) granted paediatric-use marketing authorization for melatonin. We used the European Medicines Agency (EMA) database to compare the distribution of melatonin adverse drug reaction (ADRs) between the pediatric and the adult population. The results will serve as a basis for future research involving melatonin use in specific populations. All ADR reports received in EMA up to 23.03.2019 were analyzed for overall numbers, age and gender. The nature of the ADRs and the most frequently reported drug substances and drug event combinations were evaluated using MedDRA 21.0. As of 27th March 2019, EudraVigilance contained 1061 spontaneous reports. After excluding all the cases with other suspected or concomitant drugs, we are left with 177 cases. In children ADRs were generally associated with central nervous system (CNS) excitability, whereas in adults there was mainly inhibition. The present study focused on the ADR reports of melatonin in one of the largest databases. Future research of melatonin in the pediatric population is needed, because the current SmPCs lack such information, and in the cases of melatonin use in children are increasing in recent years.



中文翻译:

向欧洲药品管理局报告的褪黑激素的儿科和成人疑似神经精神不良药物反应之间的差异

摘要

褪黑激素自 2007 年起在欧洲被批准作为睡眠药物。这种物质的药理剂量远高于生理剂量,因此它具有许多潜在的副作用也就不足为奇了。在儿童中,褪黑激素已在标签外使用多年,但在 2018 年,人用药品委员会 (CHMP) 授予了褪黑激素儿科使用的营销授权。我们使用欧洲药品管理局 (EMA) 数据库来比较儿科和成人人群中褪黑激素药物不良反应 (ADR) 的分布情况。结果将作为未来研究的基础,涉及特定人群中褪黑激素的使用。对截至 2019 年 3 月 23 日在 EMA 收到的所有 ADR 报告的总数、年龄和性别进行了分析。使用 MedDRA 21.0 评估 ADR 的性质以及最常报告的药物物质和药物事件组合。截至 2019 年 3 月 27 日,EudraVigilance 包含 1061 份自发报告。排除所有疑似或伴随药物的病例后,我们剩下177例。在儿童中,ADR 通常与中枢神经系统 (CNS) 兴奋性有关,而在成人中则主要是抑制。本研究的重点是最大数据库之一中褪黑激素的 ADR 报告。未来需要对儿科人群中的褪黑激素进行研究,因为目前的 SmPC 缺乏此类信息,而且近年来儿童中褪黑激素的使用正在增加。EudraVigilance 包含 1061 份自发报告。排除所有疑似或伴随药物的病例后,我们剩下177例。在儿童中,ADR 通常与中枢神经系统 (CNS) 兴奋性有关,而在成人中则主要是抑制。本研究的重点是最大数据库之一中褪黑激素的 ADR 报告。未来需要对儿科人群中的褪黑激素进行研究,因为目前的 SmPC 缺乏此类信息,而且近年来儿童中褪黑激素的使用正在增加。EudraVigilance 包含 1061 份自发报告。排除所有疑似或伴随药物的病例后,我们剩下177例。在儿童中,ADR 通常与中枢神经系统 (CNS) 兴奋性有关,而在成人中则主要是抑制。本研究的重点是最大数据库之一中褪黑激素的 ADR 报告。未来需要对儿科人群中的褪黑激素进行研究,因为目前的 SmPC 缺乏此类信息,而且近年来儿童中褪黑激素的使用正在增加。本研究的重点是最大数据库之一中褪黑激素的 ADR 报告。未来需要对儿科人群中的褪黑激素进行研究,因为目前的 SmPC 缺乏此类信息,而且近年来儿童中褪黑激素的使用正在增加。本研究的重点是最大数据库之一中褪黑激素的 ADR 报告。未来需要对儿科人群中的褪黑激素进行研究,因为目前的 SmPC 缺乏此类信息,而且近年来儿童中褪黑激素的使用正在增加。

更新日期:2021-06-05
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