The FDA divides drugs into five pregnancy risk categories, or classes. The five classes are A,B,C,D, and X. The meaning of the classification system is as follows:
- Class A - Adequate, well-controlled studies in pregnant women have not shown an increased risk of fetal abnormalities to the fetus in any trimester of pregnancy.
- Class B - Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled 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 in any trimester. - Class 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. - Class D - Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus.
However the benefits of therapy may outweigh the potential risk. For example, the drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective. - Class X - Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of risk of fetal abnormalities or risks.
(last reviewed June 13, 2007)