Drug Use Categories in Pregnancy

FDA CATEGORIZATION OF DRUGS FOR USE IN PREGNANCY

Category	Description
A	Adequate, well-controlled studies in pregnant women have not shown an increased risk of fetal abnormalities.
B	Animal studies have revealed no evidence of harm to the fetus; however, there are no adequate and wellcontrolled studies in pregnant women. Or
	Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus.
C	Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. Or
	No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.
D	Studies, adequate well-controlled or observational, in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk.
X	Studies, adequate well-controlled or observational, in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. The use of the product is contraindicated in women who are or may become pregnant.