PPI Use in Early Pregnancy Not Linked to Birth Defects

No risk to fetus seen if women take proton-pump inhibitors for gastroesophageal reflux

WEDNESDAY, Nov. 24 (HealthDay News) -- The use of proton-pump inhibitors (PPIs) by pregnant women in the first trimester to treat the symptoms of gastroesophageal reflux does not significantly increase the risk of major birth defects, according to a study in the Nov. 25 issue of the New England Journal of Medicine.

Björn Pasternak, M.D., and Anders Hviid, of the Statens Serum Institut in Copenhagen, Denmark, and colleagues assembled data from nationwide registries on pregnancies during 1996 to 2008, including maternal exposure to PPIs (from four weeks before conception through the first trimester) and the incidence of major birth defects in children diagnosed in the first year after birth.

There were 5,082 cases of maternal exposure to PPIs among the 840,968 births during the study period. In the PPI-exposed group, the researchers found that there were 174 major birth defects (3.4 percent), compared to 21,811 major birth defects in the non-PPI-exposed group (2.6 percent). For cases in which the PPI exposure occurred within the first trimester, there were 118 major birth defects (3.2 percent).

"In this nationwide cohort study, we found no significant association between the use of PPIs during the first trimester of pregnancy and the risk of major birth defects. These results provide reassurance that PPIs, and omeprazole in particular, can be used relatively safely during the first trimester," the authors conclude.

The editorial author disclosed a financial relationship with Merck.

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