Aim: To assess the safety of proton pump inhibitors during pregnancy.
Methods: Fifty-one pregnant women exposed to proton pump inhibitors around
the time of conception or during pregnancy were compared with 13 327 contro
ls without exposure to any prescribed drug in a population-based study base
d on The Pharmaco-Epidemiological Prescription Database of North Jutland an
d the Danish Hospital Discharge Registry,
Results: Three babies with malformations were found among 38 women exposed
to proton pump inhibitors from 30 days before conception to the end of the
first trimester. No cases of stillbirth were recorded. Crude relative risks
of malformation, low birth weight and preterm delivery were 1.6 (95% CI: 0
.5-5.1), 1.8 (95% CI: 0.2-13.0) and 2.3 (95% CI: 0.9-6.0), respectively.
Conclusions: In this population-based follow-up study, we found no substant
ially elevated risk in terms of malformations, low birth weight or number o
f preterm deliveries in pregnancies exposed to proton pump inhibitors. Howe
ver, further monitoring is warranted in order to establish or rule out a po
tential association the use of proton pump inhibitors and risk of either ca
rdiac malformations or between increased preterm birth.