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【medical-news】孕妇应避免服用抗抑郁药
Pregnant Women, Those Planning Pregnancy Should Avoid Taking Antidepressant Paxil, ACOG Opinion Says
Pregnant women or those who are planning for pregnancy should avoid taking GlaxoSmithKline's antidepressant Paxil because it can increase the risk of birth defects, according to an opinion published by an American College of Obstetricians and Gynecologists committee in the December issue of ACOG's journal Obstetrics & Gynecology, the AP/Seattle Post-Intelligencer reports (AP/Seattle Post-Intelligencer, 11/30). ACOG's Committee on Obstetric Practice's opinion recommends that women who were exposed to Paxil in early pregnancy should consider having a fetal echocardiography, which detects heart trouble HealthDay News/Forbes reports (HealthDay News/Forbes, 11/29). FDA in December 2005 issued a public health advisory warning pregnant women and physicians about an increased risk of fetal heart defects from taking Paxil -- known generically as paroxetine -- during the first three months of pregnancy. The warning moved Paxil to Category D, FDA's second-highest category for risk of birth defects. According to FDA, Category D means that either "controlled or observational" studies of pregnant women "have demonstrated a risk to the fetus." The advisory was based on previous studies that questioned the safety of using Paxil during pregnancy. One study found an increased risk of an infant experiencing a potentially fatal lung disorder if the woman takes a group of antidepressants called selective serotonin reuptake inhibitors during pregnancy, and two other studies found that use of Paxil during pregnancy could cause cardiac fetal heart defects. Before the advisory, Paxil had been classified as a Category C drug for pregnant women, which means comprehensive studies of its effects during pregnancy have not been performed (Kaiser Daily Women's Health Policy Report, 12/9/05). 最近比较忙，认领这篇 妊娠及计划怀孕的妇女应避免服用抗抑郁药帕罗西汀
AP/西雅图通讯报道，根据美国大学妇产科委员会（ACOG）在12月发表在ACOG妇产科杂志上的观点，由于可增加出生缺陷患儿的风险，妊娠及计划怀孕的妇女应避免服用抗抑郁药Paxil，ACOG建议那些妊娠早期暴露于Paxil的妇女应考虑行胎儿心超声检查，将有助于发现心脏疾患，健康日新闻/福布斯于11/29报道。FDA在2005年12月发布了公众健康公告，警告怀孕妇女及内科医生关于在妊娠早期3个月内服用Paxil－帕罗西汀会增加胎儿心脏缺陷的风险，该警告把Paxil归为D类，FDA证实发生出生缺陷风险的第二高风险类别。根据FDA，D类药物意味着存在可控制或观察到的证据显示，该类药物对于怀孕妇女来说对胎儿有致畸风险，这些忠告是建立在以往的研究基础上的，在妊娠期间应用Paxil，其安全性存在疑问。其中一项研究发现，如果妊娠期间服用称为选择性5羟色胺再吸收抑制剂一类的抗抑郁药物，婴儿患潜在致死性肺损害的风险增加，另两项研究发现，妊娠期间服用Paxil可导致婴儿心脏缺损。在该忠告发布之前，对于妊娠妇女Paxil 被归为C类，意思是妊娠期间对其药物效应已经进行了广泛研究。 背景知识：FDA妊娠药物的分级
FDA根据药物对动物和人类所具有不同程度的致畸危险，将妊娠药物分五级：A、B、C、D、X级，供临床选择孕期安全用药参考。
A 类： 在妇女的对照研究中，未发现药物对妊娠初期，中期和后期的的胎儿有危险，对胎儿伤害的可能性很小。
B 类： 在怀孕妇女的对照研究中，药物对妊娠初期，中期和后期的的胎儿危险的证据不足或不能证实。
C 类： 动物实验显示药物能造成胎仔畸形或死亡，但无妇女对照研究，使用时必须谨慎权衡药物对胎儿的潜在危险。
D 类： 药物对人类胎儿危险的证据确凿，孕妇使用必须权衡利害，仅在妇女生命受到威胁或患有严重疾病非用不可时方可使用。
X 类： 在动物或人类中的研究已表明，药物可导致胎儿异常。已怀孕或可能怀孕的妇女禁用。 [标签:content1][标签:content2]
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作者:admin@医学,生命科学 2011-05-28 17:14
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