FDA PREGNANCY CATEGORY CLASSIFICATIONS

Question 1

controlled studies in woman fail to demonstrate a risk to the fetus in the first trimester and the possibility of fetal harm appears remote

Answer 1

A

Question 2

either animal reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant woman, or animal reproduction studies have shown an adverse effect that was not confirmed in controlled studies in women in the first trimester

Answer 2

B

Question 3

animal studies reveal adverse effects on fetus and no controlled studies in woman or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus

Answer 3

C

Question 4

there is positive evidence of human fetal risk, but the benefits from use in pregnant woman may be acceptable despite the risk

Answer 4

D

Question 5

studies in animals or human beings have demonstrated fetal abnormalities, there is evidence of fetal risk based on human experience, or both, and the risk of the use of the drug in pregnant woman clearly outweigh any possible benefit. The drug is contraindicated in woman who are or may become pregnant

Answer 5

X