U.S. Food and Drug Administration (FDA) Pregnancy Categories
Categories-
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Category A
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Category B
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Category C
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Category D
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Category X
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Inferences-
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Adequate,
well-controlled studies in pregnant women have not shown an increased risk of
fetal abnormalities.
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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 an adverse effect, but adequate and well-controlled
studies in pregnant women have failed to demonstrate a risk to the fetus.
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Animal
studies have shown an adverse effect and 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 pregnant women.
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Studies,
adequate well-controlled or observational, in pregnant women have
demonstrated a risk to the fetus. However, the benefits of therapy may
outweigh the potential risk.
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Studies,
adequate well-controlled or observational, in animals or pregnant women have
demonstrated positive evidence of fetal abnormalities. The use of the product
is contraindicated in women who are or may become pregnant.
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Source:
COMMENTS