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  • Title: Use of omeprazole during pregnancy--no hazard demonstrated in 955 infants exposed during pregnancy.
    Author: Källén BA.
    Journal: Eur J Obstet Gynecol Reprod Biol; 2001 May; 96(1):63-8. PubMed ID: 11311763.
    Abstract:
    OBJECTIVES: To evaluate the magnitude of possible fetal risks involved in maternal use of omeprazole during pregnancy. STUDY DESIGN: Infants whose mothers used omeprazole during pregnancy were identified from the Swedish Medical Birth Registry. A total of 955 exposed infants born in 1995-1999 were identified: 863 of which were exposed in early pregnancy and 131 later in pregnancy and 39 who had been exposed both in early and late pregnancy. Delivery outcome was studied: presence of congenital malformations, perinatal survival, low birth weight, low Apgar score and hospitalization up to the end of 1997. RESULTS: No clear-cut indication of ill effects were seen. Five infants were stillborn and the rate of congenital heart defects was slightly increased, but both effects may be random. CONCLUSIONS: The present dataset and previously published data give no reason for concern after exposure for omeprazole during pregnancy.
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