Table 1-2. FDA pregnancy categories. The following definitions have been established to as

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Table 1-2. FDA pregnancy categories. The following definitions have been established to assign drugs to appropriate categories for use in pregnant women. Modified and reproduced from FDA Drug Bulletin, 1982; 12: 24. Regardless of the designated Pregnancy Category or presumed safety, no drug should be administered during pregnancy unless it is clearly needed. ______________________________________________________________________ CATEGORY DEFINITION __________________________________________________________________________ A Controlled studies in women fail to demonstrate a risk to the fetus in the first trimester, and the possibility of fetal (Safest) harm seems remote. __________________________________________________________________________ B Animal studies do not indicate a risk to the fetus and there are no controlled human studies, OR animal studies do show an adverse effect on the fetus but well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus. ___________________________________________________________________________ C Studies have shown the drug to have animal teratogenic or embryocidal effects, but there are no controlled studies in women OR no studies are available in either animals or women. ___________________________________________________________________________ D Positive evidence of human fetal risk exists, but benefits in certain situations (eg, life-threatening situations or diseases for which safer drugs cannot be used or are ineffective) may make use of the drug acceptable despite its risks. __________________________________________________________________________ X Studies in animals or humans have demonstrated fetal abnormal- ities or there is evidence of fetal risk based on human (Least experience, or both, and the risk clearly outweighs any safe) possible benefit. __________________________________________________________________________ Back to Table of Contents

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