Eulexin (oral) Pregnancy Warnings
This drug is not indicated for use in females.
AU TGA pregnancy category: This drug is not indicated for use in females and has not been assigned to a TGA pregnancy category.
US FDA pregnancy category: D
Comments:
-This drug is not indicated for use in females.
-The effects in a developing fetus are unknown.
Animal studies revealed a slight increase in minor variations in the development of the sternebrae and vertebrae and feminization of males in fetuses of mothers treated with doses 9 to 19 times the recommended human dose. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.
AU Exempt: Medications exempted from pregnancy classification are not absolutely safe for use in pregnancy in all circumstances. Some exempted medicines, for example the complementary medicine, St John's Wort, may interact with other medicines and induce unexpected adverse effects in the mother and/or fetus.
US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
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