Alder Hey Children's NHS Foundation Trust, Eaton Road, Liverpool, L12 2AP, UK.
Eur J Clin Pharmacol. 2012 Jan;68(1):21-8. doi: 10.1007/s00228-011-1097-1. Epub 2011 Jul 22.
The use of unlicensed and off-label medicines in children is common because trials in children have not usually been performed during the drug development process. Consequently, the information available to paediatricians may not always be as detailed or as robust as that available when prescribing a medicine that is licensed for an approved indication. This has led to concerns that children may be receiving drugs at dosages that either lack efficacy or present safety problems. The latter in particular has received a great deal of attention. In this narrative review, we have evaluated the use of off-label and unlicensed medicines in children and whether and how frequently this predisposes to adverse drug reactions.
在儿童中使用未经许可和标签外的药物是很常见的，因为在药物开发过程中通常不会在儿童中进行试验。因此，儿科医生可用的信息可能并不总是像为具有批准适应症的药物开处方时那样详细或可靠。这导致人们担心儿童可能会接受缺乏疗效或存在安全问题的药物。后者尤其受到了极大的关注。在本次叙述性综述中，我们评估了标签外和未许可药物在儿童中的使用情况，以及这种情况是否以及如何频繁导致药物不良反应。
