USE OF PROTON PUMP INHIBITORS (PPIs) IN PREGNANCY

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(Date of issue: July 2021, Version: 3)

This is a UKTIS monograph for use by health care professionals. For case-specific advice please contact UKTIS on 0344 892 0909. To report an exposure please download and complete a pregnancy reporting form. Please encourage all women to complete an online reporting form.

A corresponding patient information leaflet on omeprazole use in pregnancy is available at www.medicinesinpregnancy.org.

Summary

Proton Pump Inhibitors (PPIs), omeprazole, lansoprazole, esomeprazole, pantoprazole and rabeprazole are used in the management of dyspepsia, gastro-oesophageal reflux and peptic ulceration. The manufacturer of omeprazole state that it may be used in pregnancy if required.

Although a large meta-analysis indicated an increased risk of any malformation for PPIs as a class, there are methodological flaws associated with this analysis, and combination of the highest quality evidence did not indicate an increased risk of malformation following first trimester PPI exposure. Data from other studies for individual PPIs do not demonstrate that PPI exposure during early pregnancy increases the overall risk of congenital malformation. However, the available data for esomeprazole, pantoprazole, lansoprazole and rabeprazole is currently limited.

There is currently no evidence that gestational use of PPIs as a class is associated with an increased risk of miscarriage, preterm delivery, low birth weight or stillbirth. Data regarding these outcomes for lansoprazole, esomeprazole, pantoprazole and rabeprazole are currently too limited to allow an evidence-based assessment of their pregnancy safety profile. The data for omeprazole are currently reassuring, but also limited. There are no data on neurodevelopmental outcomes in children exposed to PPIs in utero.

Studies have shown that gastric acid suppression during pregnancy may increase the likelihood of atopy in the infant. There is some evidence that this effect may not be drug-specific. The currently available data on PPIs are, however, limited and conflicting; more research is therefore required before a link can be confirmed or refuted.

Exposure to a PPI at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy or any additional fetal monitoring. However, other risk factors may be present in individual cases which may independently increase the risk of adverse pregnancy outcome. Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments.

This document is regularly reviewed and updated. Only use UKTIS monographs downloaded directly from TOXBASE.org or UKTIS.org to be sure you are using the most up-to-date version.

This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to health care professionals at www.toxbase.org.

If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.

If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.

Disclaimer: Every effort has been made to ensure that this monograph was accurate and up-to-date at the time of writing, however it cannot cover every eventuality and the information providers cannot be held responsible for any adverse outcomes of the measures recommended. The final decision regarding which treatment is used for an individual patient remains the clinical responsibility of the prescriber. This material may be freely reproduced for education and not for profit purposes within the UK National Health Service, however no linking to this website or reproduction by or for commercial organisations is permitted without the express written permission of this service. This document is regularly reviewed and updated. Only use UKTIS monographs downloaded directly from TOXBASE.org or UKTIS.org to ensure you are using the most up-to-date version.