Esomeprazole is the s-isomer of omeprazole. In four population-based cohort studies that included 1226 women exposed during the first trimester of pregnancy to omeprazole there was no increased risk of congenital anomalies.

Reproductive studies with esomeprazole have been performed in rats at doses up to 57 times the human dose and in rabbits at doses up to 35 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus. [ See Animal Toxicology and/or Pharmacology (13.2)].

Reproductive studies conducted with omeprazole on rats at oral doses up to 56 times the human dose and in rabbits at doses up to 56 times the human dose did not show any evidence of teratogenicity. In pregnant rabbits, omeprazole at doses about 5.5 to 56 times the human dose produced dose-related increases in embryo-lethality, fetal resorptions, and pregnancy loss. In rats treated with omeprazole at doses about 5.6 to 56 times the human dose, dose-related embryo/fetal toxicity and postnatal developmental toxicity occurred in offspring.

8.3Nursing Mothers
Omeprazole concentrations have been measured in breast milk of one woman taking omeprazole 20 mg per day. However, the excretion of esomeprazole in milk has not been studied. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for tumorigenicity shown for NEXIUM in rat carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

8.4Pediatric Use
The safety and effectiveness of NEXIUM have been established in pediatric patients 1 to 17 years of age for short-term treatment (up to eight weeks) of GERD. However, effectiveness has not been demonstrated in patients less than 1 year of age.

1 to 17 years of age

Use of NEXIUM in pediatric and adolescent patients 1 to 17 years of age for short-term treatment (up to eight weeks) of GERD is supported by: a) extrapolation of results, already included in the currently approved labeling, from adequate and well-controlled studies that supported the approval of NEXIUM for adults, and b) safety and pharmacokinetic studies performed in pediatric and adolescent patients [see Clinical Pharmacology (12.3), Dosage and Administration (2), Adverse Reactions (6.1), and Clinical Studies, (14.3)]. The safety and effectiveness of NEXIUM for other pediatric uses have not been established.

Neonates to less than one year of age

There was no statistically significant difference between NEXIUM and placebo in the rate of discontinuation in a multicenter, randomized, double-blind, controlled, treatment-withdrawal study of patients ages 1 to 11 months, inclusive. Patients were enrolled if they had either a clinical diagnosis of suspected GERD, symptomatic GERD, or endoscopically proven GERD. All patients received NEXIUM Delayed-Release Oral Suspension once daily during a two-week, open-label phase of the study. There were 80 patients who attained a pre-specified level of symptom improvement and who entered the double-blind phase, in which they were randomized in equal proportions to r