Fetal Risk

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S - omeprazole

B

1. Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. 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. There are, however,no adequate and well-controlled studies in pregnant women.


2. Animal reproduction studies have shown an adverse effect (other than decrease in fertility), but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus during the first trimester of pregnancy (and there is no evidence of a risk in later trimesters). Reproduction studies have been performed on experimental animals at certain doses and have revealed evidence of harm to the fetus due to this drug. Studies in pregnant women, however, have not shown that drug increases the risk of abnormalities when administered during the first (second, third, or all) trimester(s) of pregnancy. Despite the animal findings, it would appear that the possibility of fetal harm is remote, if the drug is used during pregnancy.

Group 4

Ausreichende Erfahrungen über die Anwendung beim Menschen liegen nicht vor. Der Tierversuch erbrachte keine Hinweise auf embryotoxische/teratogene Wirkungen.

Insufficient data are available on use in humans. Animal experiment showed no indication of embryotoxic/teratogenic effects.

B3

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 have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.