Category C in FDA for drug used in pregnancy:
a- controlled studies fail to demonstrate a risk to the fetus in the trimester and there is no evidence of risk in later trimester.
b- fetal risk NOT demonstrated in animal studies but there are no controlled studies in pregnant women or animal reproduction studies have shown an adverse effect that was NOT confirmed in controlled studies in women during trimester.
c- either animal study have revealed adverse effect on the fetus and there are no controlled human studies or studies in animal and women are not available.
d- There is positive evidence of human fetal risk but the benefits of use in pregnant woman may be acceptable despite the risk.
a- controlled studies fail to demonstrate a risk to the fetus in the trimester and there is no evidence of risk in later trimester.
b- fetal risk NOT demonstrated in animal studies but there are no controlled studies in pregnant women or animal reproduction studies have shown an adverse effect that was NOT confirmed in controlled studies in women during trimester.
c- either animal study have revealed adverse effect on the fetus and there are no controlled human studies or studies in animal and women are not available.
d- There is positive evidence of human fetal risk but the benefits of use in pregnant woman may be acceptable despite the risk.