Drugs are assigned a pregnancy risk factor category ranging from A through E, and sometimes X by the Food and Drug Administration, depending on what has been learned about the drug through prior animal and human studies. If you are pregnant, or are planning to becoming pregnant, check with your doctor or pharmacist before taking any medications or supplements.
FDA Pregnancy Risk Factor Categories
* Category A: Controlled studies in women failed to demonstrate a risk to the fetus in the first or subsequent trimesters. Possibility of fetal harm seems remote.
* Category B: Animal reproduction studies have not demonstrated fetal risk, and there are no adequate human studies OR animal studies have demonstrated adverse effects, but human studies have not demonstrated fetal risk.
* Category C: Animal studies have demonstrated adverse fetal effects, but there are no adequate human studies. Benefits to the mother may outweigh potential risks to the fetus.
* Category D: Positive evidence of human fetal risk is demonstrated in human studies or post-approval data, but benefits to the mother may outweigh potential risks to the fetus, and safer drugs cannot be used or are ineffective.
* Category E: Animal or human studies demonstrated fetal abnormalities, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
* Category X: Strong evidence that the drug causes birth defects, either in humans or in animals, and fetal risks outweigh any possible benefit.
FDA Pregnancy Risk Factor Categories
* Category A: Controlled studies in women failed to demonstrate a risk to the fetus in the first or subsequent trimesters. Possibility of fetal harm seems remote.
* Category B: Animal reproduction studies have not demonstrated fetal risk, and there are no adequate human studies OR animal studies have demonstrated adverse effects, but human studies have not demonstrated fetal risk.
* Category C: Animal studies have demonstrated adverse fetal effects, but there are no adequate human studies. Benefits to the mother may outweigh potential risks to the fetus.
* Category D: Positive evidence of human fetal risk is demonstrated in human studies or post-approval data, but benefits to the mother may outweigh potential risks to the fetus, and safer drugs cannot be used or are ineffective.
* Category E: Animal or human studies demonstrated fetal abnormalities, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
* Category X: Strong evidence that the drug causes birth defects, either in humans or in animals, and fetal risks outweigh any possible benefit.
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