Fetal Risk

Active Ingredient Index

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nicotinic acid (Recommended Dietary Allowance - RDA)

A

Adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of a risk in later trimesters). Studies in pregnant women have not shown that drug increases the risk of fetal abnormalities if administered during the first (second, third, or all) trimester(s) of pregnancy. If this drug is used during pregnancy, the possibility of fetal harm appears remote. Animal reproduction studies are also available and they fail to demonstrate a risk to the fetus. Reproduction studies have been performed on experimental animals at certain doses and have revealed no evidence of impaired fertility or harm to the fetus due to this drug.

Group 5

Ausreichende Erfahrungen über die Anwendung beim Menschen liegen nicht vor.

Insufficient data are available on use in humans.

B2

Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.