Delivery outcome after the use of acid-suppressing drugs in early pregnancy with special reference to omeprazole

Objective To study delivery outcome after maternal use of acid-suppressing drugs during early pregnancy. Design Cohort study of women identified by interview in early pregnancy. Population Sweden women giving birth from 1995 to early 1997. Methods Comparison of infants exposed to acid-suppressing drugs with all births in 1995-1996. Main outcome measures Presence of congenital malformations. Results Proton pump blockers were used by 275 women, H-2 receptor antagonists by 255 women, and both categories of drugs by 20 women. No effect of the use of omeprazole or H-2-receptor antagonists on the rate of congenital malformations could be demonstrated. Conclusions Though a teratogenic effect of these drugs cannot be completely ruled out, the individual risk after exposures during the first trimester seems to be negligible.