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KMID : 0605720180240020077
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Journal of the Korean Society of Biological Therapies in Psychiatry
2018 Volume.24 No. 2 p.77 ~ p.86
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Pregnancy and Psychotropic Drugs : Understanding the New FDA Labeling Rules and Pharmacotherapy
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Woo Jung-Min
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Abstract
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According to the report of World Health Organization, about 10% of pregnant women and 13% of women who have just delivered have a mental illness. Maternal mental illness can affect not only on the mother but also on the fetus mentally and physically. Therefore, active treatments including medication have to be considered. However, a lot of women still refuse to take medications even though their symptoms are not controlled or the risk of relapse is high, due to the fear of fetal malformations when they become aware of their pregnancy. The decision on the administration of medication could be difficult in terms of the conflicting values of maternal illness and fetal safety. The appraisal for drug risk has been based on the pregnancy A, B, C, D, X categories of the United States Food and Drug Administration(FDA) so far. However, it has been criticized for evoking an excessive anxiety for teratogenicity. Fortunately, over time, data on drugs have been accumulated and new FDA pregnancy and lactation labeling rule(PLLR or final rule) was adopted recently. In this historical turning point, the psychotropic treatment for pregnant women would be reviewed.
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KEYWORD
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Psychotropic drugs, Pregnancy, Fetus, Malformation, New FDA labeling
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