PPIs in early pregnancy not associated with birth defects

January 01, 0001

PPIs in early pregnancy not associated with birth defects

These Danish authors conducted a cohort study to assess the association between exposure to proton-pump inhibitors (PPIs) during pregnancy and the risk of major birth defects among all infants born alive in Denmark between January 1996 and September 2008. They linked data from nationwide registries, including individual-level information on exposure to PPIs (prescriptions), birth defects, and potential confounders. Major birth defects, diagnosed within the first year of life, were categorized according to the standardized classification scheme of the European surveillance of congenital anomalies (EUROCAT). Our primary analyses assessed the use of PPIs from 4 weeks before conception through 12 weeks of gestation and from 0 through 12 weeks of gestation (first trimester).

They found: "Among 840,968 live births, 5082 involved exposure to PPIs between 4 weeks before conception and the end of the first trimester of pregnancy. There were 174 major birth defects in infants whose mothers had been exposed to PPIs during this period (3.4%), as compared with 21,811 in the group whose mothers had not been exposed (2.6%) (adjusted prevalence odds ratio, 1.23; significant). In analyses limited to exposure during the first trimester, there were 118 major birth defects among 3651 infants exposed to PPIs (3.2%), and the adjusted prevalence odds ratio was 1.10 (not significant). The risk of birth defects was not significantly increased in secondary analyses of exposure to individual PPIs during the first trimester or in analyses limited to the offspring of women who had filled PPI prescriptions and received enough doses to have a theoretical chance of first- trimester exposure."

The authors concluded: "In this large cohort, exposure to PPIs during the first trimester of pregnancy was not associated with a significantly increased risk of major birth defects."

This is reassuring enough that omeprazole (the most commonly prescribed PPI) could be considered acceptable to use in early pregnancy.

For the full abstract, click here.

N Engl J Med 363:2114-2123, 25 November 2010 © 2010 to the Massachusetts Medical Society
Use of Proton-Pump Inhibitors in Early Pregnancy and the Risk of Birth Defects. Björn Pasternak, and Anders Hviid. Correspondence to Dr. Pasternak: [email protected]

Category: W. Pregnancy, Childbirth, Family Planning. Keywords: pregnancy, birth defects, proton-pump inhibitors, PPIs, cohort study, journal watch.
Synopsis edited by Dr Linda French, Toledo, Ohio. Posted on Global Family Doctor 14 December 2010

Pearls are an independent product of the Cochrane primary care group and are meant for educational use and not to guide clinical care.