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【drug-news】美国FDA对拉莫三嗪的最新警告2006-9-
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FDA ALERT [9/2006]
New information suggests that babies exposed to Lamictal during the first three months of pregnancy may have a higher chance of being born with a cleft lip or cleft palate. Babies born with cleft lip or cleft palate have a gap in the upper lip or roof of the mouth.
If you take Lamictal and are pregnant or are thinking of becoming pregnant, talk with your doctor. Lamictal is used for seizures or bipolar disorder, serious conditions that need treatment even during pregnancy. Do not start or stop using Lamictal without talking to your doctor.
More research is needed to be sure about this possibly increased chance of cleft lip or cleft palate in babies born to mothers who take Lamictal.
拉莫三嗪（商品名Lamictal）信息
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FDA 警告 [9/2006]
最新的信息表明，孕妇在怀孕头三个月服用过拉莫三嗪的出生婴儿，出现唇裂或颚裂的可能性较大。这些婴儿的上唇或者口腔的顶部会裂开豁口。
如果你在服用拉莫三嗪并且正在怀孕或打算怀孕，请告之你的医生。拉莫三嗪用于癫痫或双相情感性精神病，以及严重情况下的孕妇的治疗。开始服用或停药都应告之你的医生。
对于孕妇服用拉莫三嗪对婴儿的不良影响，更多的研究还在进行中。
【通用名】拉莫三嗪片 片剂 50mg
【汉语拼音】Lamosanping Pian
【商品名】利必通Lamictal
【英语名】Lamotrigine
【主要成份】拉莫三嗪
【化学名】3,5-二氨基-6-(2, 3-二氯苯基)-as-三吖嗪。
【分子式】C9H7N5Cl2
【分子量】256.09
【孕妇及哺乳期妇女用药】
生育力：在动物的生殖实验中，本品不损害生育力。
本品对人类生育力的影响尚无经验。
致畸性：本品是一种弱的二氢叶酸还原酶抑制剂。妊娠期母亲使用叶酸抑制剂治疗时，理论上有胎儿致畸的危险 今天刚刚看到的，作为补充
U.S. says Glaxo drug may be linked to birth defect
Sep 29, 2006 — By Lisa Richwine
WASHINGTON (Reuters) - Taking GlaxoSmithKline Plc's Lamictal epilepsy drug during the first three months of pregnancy may increase the chances of having a baby with a cleft lip or palate, U.S. regulators warned on Friday.
"More research is needed to be sure about this possibly increased chance of cleft lip or cleft palate in babies born to mothers who take Lamictal," the Food and Drug Administration said in an alert posted on its Web site at http://www.fda.gov/cder/drug/infopage/lamotrigine/default.htm.
Women who are pregnant or thinking of becoming pregnant should not stop taking Lamictal without talking to a doctor, the FDA said. The drug's generic name is lamotrigine.
"Lamictal is used for seizures or bipolar disorder, serious conditions that need treatment even during pregnancy," the FDA said.
A spokesman for Glaxo in London said the safety and efficacy profile of Lamictal was well established but, as with all medicines, doctors had to make decisions about prescribing based on the risk/benefit profile of individual patients.
"We have been in discussions with FDA for several months on this matter. It is clear that more data is required, as the FDA have said in their advisory," he added.
The company also said information from other pregnancy registries did not replicate the findings about the cleft lips and palates, which came from a North American registry of women who took anti-epilepsy drugs during pregnancy. Glaxo voluntarily sent a letter to doctors with information from the registries in June, the spokesman said.
Lamictal sales totaled 849 million pounds ($1.59 billion) worldwide last year, with 568 million pounds generated in the United States.
Earlier this week the drug was approved by the FDA to treat one of the most serious forms of epilepsy, known as "grand mal" seizures, in children aged 2 and older as well as for adults.
Lamictal is already approved as an additional therapy to treat partial seizures and seizures associated with Lennox-Gastaut syndrome. It is also approved as a maintenance therapy for adults with bipolar disorder, or manic depression.
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作者:admin@医学,生命科学 2010-12-17 17:11
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