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5 Cards in this Set
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- Back
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Pregnancy Risk Category A
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-Adequate well-contolled studies in pregnant women have not shown an increased risk of fetal abnormalities
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Pregnancy Risk Category B
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-Animal studies have revealed no evidence of harm to the fetus; however there are no adequate and well controlled studies in pregnant women
OR -Animal studies have shown and adverse effect, but adequate and well controlled studies in pregnant women have failed to demonstrate risk to the fetus |
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Pregnancy Risk Category C
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-Animal studies have shown an adverse effect, but there are no adequate and well controlled studies in pregnant women
OR -No animal studies have been conducted and there are no adequate and well controlled studies in women |
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Pregnancy Risk Category D
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-Adequate and well controlled, observational studies in pregnant women have demonstrated a risk to the fetus
-However, the benefits of therapy may outweigh the potential risk |
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Pregnancy Risk Category X
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-Adequate and well controlled, observational studies in pregnant women have demonstrated positive evidence of fetal abnormalities
-The use of the product is contradicted in women who are or may become pregnant |
