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A pictogram on boxes of teratogenic or fetotoxic drugs

机译:关于致畸或胎毒药盒的象形图

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In late 2017 compulsory pictograms were introduced in France for boxes of teratogenic or fetotoxic drugs. Their meaning must be explained to patients, in particular at the time of dispensing. It is also worth reminding patients that even drugs without a warning pictogram should be considered dangerous during pregnancy until proven otherwise. Since 17 October 2017, in France, if a drug's summary of product characteristics (SPC) mentions a riskofteratogenicityorfetotoxicity, a pictogram to inform users of these risks must be displayed on the box (1,2).The aim of this visual warning is to raise awareness among patients and healthcare professionals of the risks some drugs pose in pregnancy. Origins in the activism of a support group for victims of valproic acid. France's national drug regulatory agency (ANSM) had already introduced a pictogram for medicines containing valproic acid or its derivatives valproate semisodium and valpromide, with effect from 1 March 2017 (3). These drugs are teratogenic: in utero exposure can provoke congenital defects and disorders of psycho-motor development (4).This measure came about through the campaigning of a French support group (Apesac) for the parents of children affected by fetal anticonvulsant syndrome. French drug regulations have been amended to impose this measure on all drugs whose SPC mentions a teratogenic or fetotoxic effect (1,2).
机译:在2017年底,强制象形文字在法国引入了致畸或胎毒药盒。它们的意义必须向患者解释,特别是在分配时。它还值得提醒患者,即使没有警告象形图的药物也应被视为怀孕期间危险,直至否认。自2017年10月17日以来,在法国,如果药物的产品特征(SPC)提及患有风险促核特征性,则以告知用户这些风险的象形图必须显示在框(1,2)上。此视觉警告的目的是提高患者和医疗保健专业人员的意识,其中一些药物在怀孕中占有。丙戊酸受害者支持群体的起源。法国的国家药物监管机构(澳门症)已经介绍了含有缬氨酸或其衍生物Valproate半石和缬氨酸的药物的象形图,其效果于2017年3月1日(3)。这些药物是致畸的:在子宫暴露中可以引发心理运动发展的先天性缺陷和疾病(4)。这一措施通过法国支持小组(APESAC)的竞争,为受胎儿抗惊厥综合征影响的儿童的父母。已经修改了法语药物规定,以对所有药物施加这一措施,其SPC提到致畸或胎毒性作用(1,2)。

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    《Prescrire international》 |2018年第190期|共2页
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  • 正文语种 eng
  • 中图分类 药学;
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