A nurse is instructing a pregnant patient concerning the potential risk to her fetus from a Pregnancy Category B drug. What would the nurse inform the patient?
A) "Adequate studies in pregnant women have demonstrated there is no risk to the fetus."
B) "Animal studies have not demonstrated a risk to the fetus, but there have been no adequate studies in pregnant women."
C) "Animal studies have shown an adverse effect on the fetus, but there are no adequate studies in pregnant women."
D) "There is evidence of human fetal risk, but the potential benefits from use of the drug may be acceptable despite potential risks."
B
Feedback:
Category B indicates that animal studies have not demonstrated a risk to the fetus. However, there have not been adequate studies in pregnant women to demonstrate risk to a fetus during the first trimester of pregnancy and no evidence of risk in later trimesters. Category A indicates that adequate studies in pregnant women have not demonstrated a risk to the fetus in the first trimester or in later trimesters. Category C indicates that animal studies have shown an adverse effect on the fetus, but no adequate studies in humans. Category D reveals evidence of human fetal risk, but the potential benefits from the use of the drugs in pregnant women may outweigh potential risks.
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