United States FDA Pharmaceutical Pregnancy Categories.
In the United States, the Food and Drug Administration (FDA) is one source of guidance. The FDA looks at the evidence available about the risk of harm if each medication is used during pregnancy. Then it assigns each one to a "Pregnancy Category" (A, B, C, D, or X). The category for each medication is reported in its package insert.
Category A : Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).
Category B :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 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.
Category C : Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Category D : There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Category X : Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
Alphabetical Drug Pregnancy Category ---- A-B | C-D | E-F| G-H | I-J-K | L-M | N-O | P-Q-R | S-T | U-V-W-Z
Last update Aug 22,2010
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