PPI exposure during early pregnancy poses no excess risk of congenital malformations | Latest news for Doctors, Nurses and Pharmacists


The use of proton pump inhibitors (PPIs) during early pregnancy does not appear to increase the risk of congenital malformations in infants, as reported in one study. However, the risk of major congenital malformations and congenital heart disease appears to be slightly increased.

This study used data from the National Health Information Database (2010-2020) of the National Health Insurance Administration of South Korea to identify 2,696,216 pregnancies of women (mean age of mother 32.1 years) and their newborns. Women exposed to known teratogens or who gave birth to babies with chromosomal abnormalities or hereditary syndromes were excluded.

Investigators evaluated the primary outcomes of major congenital malformations, congenital heart disease, cleft palate, hydrocephalus, and hypospadias associated with the use of PPIs during early pregnancy. They also performed a sibling control analysis to account for familial factors.

A total of 40,540 (1.5%) reported exposure to PPIs during early pregnancy. The absolute risks of major congenital malformations in PPI-exposed and non-exposed pregnancies were 396.7 and 323.4 per 10,000 infants, respectively.

The propensity score-adjusted relative risk associated with PPI exposure was 1.07 (95% confidence interval [CI]1.02–1.13) major congenital malformations, 1.09 (95% CI, 1.01–1.17), congenital heart disease, 1.02 (95% CI, 0.72–1.43), cleft palate, 0.94 (95% CI, 0.54–1.63) ) for hydrocephalus, hypospadias 0.77 (95% CI, 0.51–1.17).

Analysis of sib-controls showed no association of PPI use with primary outcomes, including major congenital malformations (odds ratio). [OR], 1.05, 95% CI, 0.91–1.22) and congenital heart disease (OR, 1.07, 95% CI, 0.88–1.30). The results of the sensitivity analysis were consistent with our main findings.

Current data provide evidence that can guide clinicians and patients in decision-making regarding PPI use in early pregnancy.



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