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Chapter 2

U.S. Food and Drug Administration Pregnancy Categories

QuestionAnswer
No risk to fetus per studies A
No risk in animal studies, and well-controlled studies in pregnant women not available. It is assumed there is little or no risk B
Animal studies: a risk to the fetus. Controlled studies on pregnant women not available. Risk versus benefit must be determined. C
A risk to the human fetus has been proved. Risk versus benefit must be determined D
A risk to the human fetus has been proved. Risk outweighs the benefit, and drug should be avoided during pregnancy X
Created by: 280993795864492
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