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Several published observational studies suggest that proton pump inhibitorPPItherapy may be associated with an . increased risk for osteoporosis-related fractures of the hipwristor spineThe risk of fracture was increased in patients who received high-dosedefined as multiple daily dosesand long-term PPI therapya year or longerPatients should use the lowest dose and shortest duration of PPI therapy appropriate to the conditionbeing treatedPatients at risk for osteoporosis-related fractures should be managed according to established treatment guidelinessee DOSAGE AND ADMINISTRATION and ADVERSE REACTIONS
Hypomagnesemiasymptomatic and asymptomatichas been reported rarely in patients treated with PPIs for at least three monthsin most cases after a year of therapySerious adverse events include tetanyarrhythmiasand seizuresIn most patientstreatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.
Following administration of oral NEXIUM in neonates the geometric meanrangefor the apparent clearanceCL/Fwas 0.55 L/h/kg0.25-1.6 L/h/kg
A population-based retrospective cohort study covering all live births in Denmark from 1996-2009reported on 1,800 live births whose mothers used omeprazole during the first trimester of pregnancy and 837,317 live births whose mothers did not use any proton pump inhibitorThe overall rate of birth defects in infants born to mothers with first trimester exposure to omeprazole was 2.9and 2.6in infants born to mothers not exposed to any proton pump inhibitor during the first trimester.
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