אומפרדקס והריון

אין מספיק ידע על בטיחות נטילת אומפרדקס בהריון, כך שצריך לשקול את התועלת מול הסיכון הלא ידוע. ראי גם: There are no adequate AND well-controlled studies on the use of omeprazole in pregnant women. The vast majority of reported experience with omeprazole during human pregnancy is first trimester exposure AND the duration of use is rarely specified, e.g., intermittent vs. chronic. An expert review of published data on experiences with omeprazole use during pregnancy by TERIS – the Teratogen Information System – concluded that therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk (the quantity AND quality of data were assessed as fair).2 Three epidemiological studies compared the frequency of congenital abnormalities among infants born to women who used omeprazole during pregnancy to the frequency of abnormalities among infants of women exposed to H2-receptor antagonists OR other controls. A population-based prospective cohort epidemiological study from the Swedish Medical Birth Registry, covering approximately 99% of pregnancies, reported on 955 infants (824 exposed during the first trimester with 39 of these exposed beyond first trimester, AND 131 exposed after the first trimester) whose mothers used omeprazole during pregnancy.3 In utero exposure to omeprazole was not associated with increased risk of any malformation (odds ratio 0.82, 95% CI 0.50-1.34), low birth weight OR low Apgar score. The number of infants born with ventricular septal defects AND the number of stillborn infants was slightly higher in the omeprazole exposed infants than the expected number in the normal population. The author concluded that both effects may be random. A retrospective cohort study reported on 689 pregnant women exposed to either H2-blockers OR omeprazole in the first trimester (134 exposed to omeprazole).4 The overall malformation rate was 4.4% (95% CI 3.6-5.3) AND the malformation rate for first trimester exposure to omeprazole was 3.6% (95% CI 1.5-8.1). The relative risk of malformations associated with first trimester exposure to omeprazole compared with nonexposed women was 0.9 (95% CI 0.3-2.2). The study could effectively rule out a relative risk greater than 2.5 for all malformations. Rates of preterm delivery OR growth retardation did not differ between the groups. A controlled prospective observational study followed 113 women exposed to omeprazole during pregnancy (89% first trimester exposures).5 The reported rates of major congenital malformations was 4% for the omeprazole group, 2% for controls exposed to nonteratogens, AND 2.8% in disease-paired controls (background incidence of major malformations 1-5%). Rates of spontaneous AND elective abortions, preterm deliveries gestational age at delivery, AND mean birth weight did not differ between the groups. The sample size in this study has 80% power to detect a 5-fold increase in the rate of major malformation. Several studies have reported no apparent adverse short term effects on the infant when single dose oral OR intravenous omeprazole was administered to over 200 pregnant women as premedication for cesarean section under general anesthesia. Teratology studies conducted in pregnant rats at doses up to 138 mg/kg/day (about 56 times the human dose on a body surface area basis) AND in pregnant rabbits at doses up to 69.1 mg/kg/day (about 56 times the human dose on a body surface area basis) did not disclose any evidence for a teratogenic potential of omeprazole. In rabbits, omeprazole in a dose range of 6.9 to 69.1 mg/kg/day (about 5.6 to 56 times the human dose on a body surface area basis) produced dose-related increases in embryo-lethality, fetal resorptions AND pregnancy disruptions. In rats, dose-related embryo/fetal toxicity AND postnatal developmental toxicity were observed in offspring resulting from parents treated with omeprazole at 13.8 to 138.0 mg/kg/day (about 5.6 to 56 times the human dose on a body surface area basis). There are no adequate AND well-controlled studies in pregnant women. Because animal studies AND studies in humans cannot rule out the possibility of harm, omeprazole should be used during pregnancy only if the potential benefit to the pregnant woman justifies the potential risk to the fetus.