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Omeprazole safe in early pregnancy

Clinical Question:
Is exposure to proton-pump inhibitors in early pregnancy associated with birth defects in infants?

Bottom Line:
Exposure to proton-pump inhibitors (PPIs), mainly omeprazole, during the first trimester of pregnancy did not appear to increase the risk of birth defects in this Danish cohort. Increased risks associated with lansoprazole when used within 4 weeks of conception cannot be ruled out. (LOE = 2b)

Pasternak B, Hviid A. Use of proton-pump inhibitors in early pregnancy and the risk of birth defects. N Engl J Med 2010;363(22):2114-2123.  [PMID:21105793]

Study Design:
Cohort (retrospective)



These authors compiled data from several Danish sources, to assess the risk of birth defects associated with the use of PPIs in early pregnancy. They used data from the Medical Birth Register, Prescription Drug Register, Central Person Register, and Statistics Denmark from January 1996 through September 2008. They included prescriptions filled from 4 weeks prior to the estimated date of conception to 12 weeks gestational age. However, omeprazole became available over-the-counter in December 2006 and lansoprazole in May 2007, so data are incomplete. There were 5082 live births with known maternal prescriptions for PPIs among 840,968 live births. There were 174 (3.4%) major birth defects among infants of exposed mothers compared with a rate of 2.6% among infants whose mothers were not exposed (adjusted odds ratio [OR] = 1.23; 95% CI, 1.05-1.44). Lansoprozole was significantly associated with an increase in birth defects when used within 4 weeks of conception, whereas omeprazole was not. When limited to women who received prescriptions within the first trimester the rate of birth defects was 3.2% (OR = 1.10; 0.91-1.34), and there was no significant increase with exposure to lansoprosole. A secondary analysis limited to the infants of women who had filled a prescription for a PPI either after conception or before conception with enough doses to have a first trimester exposure with assumed daily use there was not a significant increase in birth defects (OR = 1.12; 0.94-1.35).


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