Pregnancy "Category C" Labeling

An FDA Pregnancy Labeling Task Force was organized to review drug labeling information on pregnancy and fetal risks and to explore how the information could be presented to clinicians, reviewers and other interested parties in the most effective manner, in order to provide the greatest possible usefulness to the public. The long term goal is to determine how animal toxicology information contributes to clinically meaningful information. A major task of this group is the reassessment of category "C." Specific requirements on content and format of labeling for human prescription drugs states the following:

Pregnancy Category C: If animal reproduction studies have shown an adverse effect on the fetus, if there are no adequate and well-controlled studies in humans, and if the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks, the labeling shall state: "Pregnancy Category C. (Name of drug) has been shown to be teratogenic (or to have an embryocidal effect or other adverse effect) in (name(s) of species) when given in doses (x) times the human dose. There are no adequate and well-controlled studies in pregnant women. (Name of drug) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus." The labeling shall contain a description of the animal studies. If there are no animal reproduction studies and no adequate and well-controlled studies in humans, the labeling shall state: "Pregnancy Category C. Animal reproduction studies have not been conducted with (name of drug). It is also not known whether (name of drug) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. (Name of drug) should be given to a pregnant woman only if clearly needed." The labeling shall contain a description of any available data on the effect of the drug on the later growth, development, and functional maturation of the child.