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Pregnancy Categories for Drugs |
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| Category A. Adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in the first trimester and there is no evidence of risk in later trimesters. If the drug were used during pregnancy, the possibility of fetal harm appears remote. Category B. Either animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women or animal reproduction studies have shown an adverse effect (other than on fertility) but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in the first trimester and there is no evidence of risk in later trimesters. In either case, the drug should be used during pregnancy only when clearly needed. Category C. Either animal reproduction studies have revealed evidence of an adverse fetal effect and there are no adequate and well-controlled studies in pregnant women or animal reproduction studies have not been performed and it is not known whether the drug can cause fetal harm when administered to pregnant women. In the first case, the drug should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. In the latter case, the drug should be used during pregnancy only when clearly needed. Category D. There is positive evidence of human fetal risk based on adverse reaction data from investigational or postmarketing experience or studies in humans, but the potential benefits from use of the drug in pregnant women may be acceptable in certain conditions despite the possible risks to the fetus. The drug should be used during pregnancy only in life-threatening situations or severe disease for which safer drugs cannot be used or are ineffective. When the drug is administered during pregnancy or if the patient becomes pregnant while receiving the drug, the patient should be informed of the potential hazard to the fetus. Category X. The drug may (can) cause fetal toxicity when administered to pregnant women based on animal or human studies demonstrating fetal abnormalities or positive evidence of human fetal risk from adverse reaction data from investigational or postmarketing experience, or both, and the risk of use of the drug during pregnancy clearly outweighs any benefit (e.g., safer drugs or alternative therapies are available). Since the risks clearly outweigh any possible benefits in women who are or may become pregnant, the drug is contraindicated in such women. If the drug is inadvertently administered during pregnancy or if the patient becomes pregnant while receiving the drug, the patient should be informed of the potential hazard to the fetus. |
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