Is it safe to use omeprazole during pregnancy and lactation?

Fråga: Is it safe to use omeprazole during pregnancy and lactation?

Sammanfattning: Published data on a moderate number of women have not indicated that omeprazol is harmful to the fetus. The measured concentration of omeprazol in breast milk in a single woman treated with omeprazol during lactation was minimal.

Svar: This question has previously been answered by the regional drug information centers in Sweden. The conclusion has been that omeprazol is safe to use during pregnancy and lactation although clinical experience is limited (1,2).

Gastroesophageal reflux disease is one of the most common complications of pregnancy and lactation. Omeprazole, a proton pump inhibitor, has been shown to be effective in the treatment of this condition. A controlled prospective study of 113 women exposed to omeprazole during pregnancy (101 exposed during organogenesis) (3) showed no increase in the incidence of major malformations, spontaneous abortions, elective abortions, preterm deliveries and no differences in mean birth weight, gestational age at delivery, method of delivery or neonatal health problems such as jaundice and days in intensive care unit. A study of a woman who was treated with omeprazole during lactation showed peak omeprazole concentrations in breast milk that were less than 7 per cent of the peak serum concentration, indicating minimal secretion (4).