Use of omeprazole during pregnancy -: no hazard demonstrated in 955 infants exposed during pregnancy

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. (C) 2001 Elsevier science Ireland Ltd. All rights reserved.