Use of omeprazole during pregnancy--no hazard demonstrated in 955 infants exposed during pregnancy.
OBJECTIVE
To evaluate the magnitude of possible fetal risks involved in maternal use of omeprazole during pregnancy.


METHODS
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.
Källén
B A
BA
Tornblad Institute, University of Lund, Biskopsgatan 7, S-223 63, Lund, Sweden. embryol@embryol.lu.se
D000014:Abnormalities, Drug-Induced / Q000453:epidemiology*; D000015:Abnormalities, Multiple / Q000453:epidemiology; D000328:Adult; D000897:Anti-Ulcer Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001034:Apgar Score; D001724:Birth Weight; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007226:Infant Mortality; D007231:Infant, Newborn; D018811:Maternal Exposure; D008875:Middle Aged; D009853:Omeprazole / Q000009:adverse effects* / Q000627:therapeutic use; D011247:Pregnancy; D011261:Pregnancy Trimester, First; D013548:Sweden / Q000453:epidemiology
D000897:Anti-Ulcer Agents; D009853:Omeprazole