USE OF PROTON PUMP INHIBITORS (PPIs) IN PREGNANCY

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(Date of issue: August 2015, Version: 2)

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) are used in the management of dyspepsia, gastro-oesophageal reflux and peptic ulceration. Of the five PPIs licensed for use in the United Kingdom (omeprazole, lansoprazole, esomeprazole, pantoprazole and rabeprazole) only omeprazole, for which there is the most documented data on pregnancy outcome following exposure, is licensed for use in pregnancy. 

Studies of PPIs as a group, or omeprazole individually, have not shown that in utero exposure during the first trimester is associated with an increased overall risk of congenital malformation in the infant, or with a number of specific malformations. Although a single study suggested a possible link between PPI use in pregnancy and hypospadias in male infants, the findings of two further studies do not support this.

There is no evidence that use of PPIs as a group, or omeprazole individually, in pregnancy is associated with an increased risk of preterm delivery or low birth weight in the infant. Data on spontaneous abortion and stillbirth are too limited to allow conclusions to be drawn regarding whether rates may be affected by use of PPIs in pregnancy. 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, and more research is required before a link can be confirmed or refuted.

There are insufficient data on the other individual PPIs (lansoprazole, esomeprazole, pantoprazole and rabeprazole) to permit an evidence-based assessment of their pregnancy safety profile, and pregnant women taking PPIs other than omeprazole should be made aware of this lack of data.

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.