The recent multicentre, prospective controlled cohort study mentioned above followed 295 pregnancies exposed to PPIs, including 53 exposed to pantoprazole, and compared pregnancy outcomes with those of 868 control subjects.6 Rate of major congenital malformations in the pantoprazole group was 2.1% (1/48) compared with 3.8% in the control group (30/792). There was no pattern of anomalies.
A 42-year-old woman was studied over a 24-hour period after oral administration of 40 mg of pantoprazole.8 A milk-to-plasma ratio of 0.022 was observed 2 hours after drug administration. The relative dose to the infant was estimated to be 7.3 μg of pantoprazole, which is equivalent to 0.14% of the weight-normalized dose received by the mother. The mother reported no adverse events in the infant. Because pantoprazole is unstable in acidic pH, the systemic dose received by the infant could have been lower.
Use Omeprazole instead
A multicentre prospective cohort study conducted by Motherisk looked at the outcomes among 113 mothers exposed to omeprazole during pregnancy, including 101 mothers exposed during organogenesis.3 Two control groups were used: a disease-paired control group using histamine H2-blockers and a control group of healthy women exposed to nonteratogenic medications. The rate of major malformations in the omeprazole group (5%) did not differ significantly from rates in the nonteratogenic drug control group (3%) and in the disease-paired control group (3%). Rates of spontaneous abortions, preterm deliveries, cesarean sections, and neonatal health problems birth weight and gestational age at delivery were also comparable in the 3 groups.
The Motherisk Program also conducted a meta-analysis on use of PPIs during pregnancy.4 All exposures to PPIs (593 cases) had a relative risk of 1.18 (95% confidence interval [CI] 0.72 to 1.94) and exposures to omeprazole only (534 cases) had a relative risk of 1.05 (95% CI 0.59 to 1.85), indicating no increase in risk of malformations.
A large cohort study from the Swedish Medical Birth Registry reported on 955 infants whose mothers used omeprazole during pregnancy.5 In this report, 863 of the infants were exposed at least during the first trimester, and 92 were exposed only after the first trimester. Birth weights, rates of congenital malformations and perinatal death, and low Apgar scores in the exposed group were comparable to rates observed in the general Swedish population.
A recent multicentre, prospective controlled cohort study followed 295 pregnancies where mothers were exposed to omeprazole (233 exposed during the first trimester), 62 pregnancies where mothers were exposed to lansoprazole, and 53 pregnancies where mothers were exposed to pantoprazole. The pregnancy outcomes of these mothers were compared with those of 868 control subjects.6 In the omeprazole group, 3.6% (9/249) of babies were born with malformations, a rate similar to the 3.8% (30/792) observed in the control group. There was no pattern of anomalies among the babies born with birth defects.
Administration of oral omeprazole to a 41-year-old woman during the third trimester of pregnancy, after ranitidine and cisapride failed to control her refractory gastroesophageal reflux disorder, was reported.7 No adverse fetal effects were apparent, and the patient elected to continue omeprazole therapy (20 mg/d) while breastfeeding. Peak omeprazole concentrations in breast milk of 58 nM at 3 hours after ingestion of the drug were lower than 7% of the peak maternal serum concentration (950 nM at 4 h), indicating limited excretion into milk.
The conclusion is:-
Overall, a rule of thumb during pregnancy is to choose an older agent in a pharmacologic class for which there are more fetal safety data that indicate the medication is effective. Applying this rule to PPIs makes omeprazole the drug of choice for now.
A cohort study of 113 women found no associated anomalies (relative risk=1.94 95% confidence interval, 0.36-10.36). Pantoprazole, lansoprazole and rabeprazole are category B medications.
Medications in category A are not contraindicated for pregnancy, and are considered to be of a high safety level. Medications in category B have never been shown to have a risk for the baby, but there are not adequate studies to rule out risk. Category C medications are not recommended for pregnant women unless the potential benefit outweighs the potential risk. Category D have proven risks that may still be outweighed by benefits. For Category X medications, there is definitely risk to the baby and the risk outweighs the benefits.
In a study published this year, 295 pregnancies exposed to omeprazole, 62 to lansoprazole and 53 to pantoprazole were compared with 868 pregnant controls for the development of congenital abnormalities. As with other studies, the rate of congenital abnormalities did not differ between the exposed and control groups: omeprazole nine of 249 (3.6%), lansoprazole two of 51 (3.9%) and pantoprazole one of 48 (2.1%) vs. controls 30 of 792 (3.8%). No differences were found when exposure was limited to the first trimester.
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