REUTERS:FDA对怀孕期间使用丙戊酸钠类药物发出警告

2013-05-09 MedSci MedSci原创

美国食品药品管理局(FDA)对孕妇使用偏头痛药物丙戊酸钠发布警告,指出丙戊酸钠可导致婴儿智商降低。FDA表示,最近的研究结果显示,在子宫中接触过丙戊酸钠产品的六岁儿童相比接触其它抗癫痫药的儿童其智商相对较低。含有丙戊酸钠的药物被用来预防偏头痛,治疗癫痫以及与躁郁症相关的躁狂发作。丙戊酸钠以商品名Depacon上市,双丙戊酸钠以商品名Depakote、Depakote CP、Depakote ER上

美国食品药品管理局(FDA)对孕妇使用偏头痛药物丙戊酸钠发布警告,指出丙戊酸钠可导致婴儿智商降低。FDA表示,最近的研究结果显示,在子宫中接触过丙戊酸钠产品的六岁儿童相比接触其它抗癫痫药的儿童其智商相对较低。
含有丙戊酸钠的药物被用来预防偏头痛,治疗癫痫以及与躁郁症相关的躁狂发作。丙戊酸钠以商品名Depacon上市,双丙戊酸钠以商品名Depakote、Depakote CP、Depakote ER上市,丙戊酸以商品名Depakene和Stavzor上市。含有丙戊酸的药品其标签内容中已加入了黑框警告,提示这类药物易致出生缺陷。
FDA神经病产品部门主任拉塞尔·卡茨说:“丙戊酸类药物绝不能用于孕妇偏头痛的预防,因为我们现在已有更多的数据显示孕妇使用这类药物对儿童的风险要远远超过治疗的收益,”。这是FDA第二次对含有丙戊酸的药物发布警告。在2011年6月的一次新闻发布会上,FDA已发布过一项研究的中期结果,显示接触过丙戊酸的三岁儿童其认知功能降低。
丙戊酸钠相关的拓展阅读:


FDA warns on use of certain migraine drugs during pregnancy
(Reuters) - The U.S. Food and Drug Administration warned on the use of migraine drug valproate sodium in pregnant women as it could result in lower IQ scores in the baby.
The FDA said the results of a recent study showed that children exposed to valproate products in the womb had lower IQ at the age of six than children who were exposed to other antiepileptics.
Drugs containing valproate are used to prevent migraine headaches, treat epileptic seizures and manic episodes associated with bipolar disorder.
Abbott Laboratories' Depacon, Depakote, Depakote CP, Depakote ER and Depakene, and Noven Therapeutics LLC's Stavzor and their generics contain valproate. (r.reuters.com/nej87t)
Drugs containing valproate already carry a boxed warning for birth defects.
"Valproate medications should never be used in pregnant women for the prevention of migraine headaches because we have even more data now that shows the risks to the children outweigh any treatment benefits for this use," FDA's Director of the Division of Neurology Products, Russell Katz said.
This is the second time the FDA has warned on drugs containing valproate. In a June 2011 press release, the regulator had issued interim results of a study showing reduced cognitive functions in three-year-old children exposed to valproate.

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    2014-03-31 anminleiryan
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