Review
Copyright ©The Author(s) 2016.
World J Gastrointest Pharmacol Ther. Nov 6, 2016; 7(4): 490-502
Published online Nov 6, 2016. doi: 10.4292/wjgpt.v7.i4.490
Table 1 Food and Drug Administration pregnancy categories
FDA categoryDefinition
AControlled studies in animals and women demonstrate no risks during the first trimester, and the possibility of fetal harm appears remote
BStudies in animals have not demonstrated a fetal risk, but no controlled studies have been conducted in pregnant women, or animal studies have shown an adverse event that was not confirmed in controlled studies in women during the first trimester. Chance of fetal harm is remote but remains a possibility
CNo controlled studies have been conducted in women, and animal studies have shown adverse effects on the fetus, or studies in humans and animals are not available. Chance of fetal harm. Give only if potential benefit outweighs the risk
DThere are no controlled studies in women or animals, but positive evidence of fetal risk is available. It can still be used for life-threatening or serious diseases when there are no effective alternative drugs
XStudies in animals or women have demonstrated fetal abnormalities. The drug is contraindicated in women who are pregnant or may become pregnant