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For Nexium, limited data on exposed pregnancies are available. Animal studies with esomeprazole do not indicate direct or indirect harmful effects with respect to embryonal/fetal development. Animal studies with the racemic mixture do not indicate direct or indirect harmful effects with respect to pregnancy, parturition or postnatal development. Caution should be exercised when prescribing Nexium to pregnant women.
It is not known whether esomeprazole is excreted in human breast milk. No studies in lactating women have been performed. Therefore, Nexium should not be used during breast-feeding.
Gastro-resistant tablet: With the racemic mixture omeprazole, data on a larger number of exposed pregnancies from epidemiological studies indicate no malformative or foetotoxic events.
