USE OF NAPROXEN IN PREGNANCY

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(Date of issue: August 2013, Version: 1)

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 naproxen use in pregnancy is available at www.medicinesinpregnancy.org.

Summary

Naproxen is a non-steroidal anti-inflammatory drug used primarily for the treatment of pain and inflammation in rheumatic disease and other musculoskeletal disorders.

Few studies have specifically investigated the fetal risks of maternal naproxen use in pregnancy.  Some studies on NSAIDs as a class have shown an association between use in pregnancy and an increased risk of cardiovascular defects in the offspring, as well as an increased risk of spontaneous abortion.  Increased rates of orofacial clefts, cardiac defects and non-isolated anophthalmia/microphthalmia have been reported in some studies of naproxen use in pregnancy.  However, other studies have failed to identify such risks, and as such, these associations remain unproven.  No studies investigating the risk of spontaneous abortion specifically following naproxen exposure were identified in the published literature. 

Chronic exposure or exposure to high doses of NSAIDs after 30 weeks of gestation is associated with an increased risk of premature closure of the ductus arteriosus and oligohydramnios.  These effects are thought to be mediated by the inhibitory effect of NSAIDs on prostaglandin production.  A single, small case-control study has identified increased rates of antenatal use of NSAID, aspirin, ibuprofen and naproxen use amongst mothers of infants with PPHN.  Further evidence is required before this possible association can be confirmed.

Where clinically indicated, treatment with naproxen in the first or second trimester   may be considered.  Naproxen should, where possible, be avoided during the third trimester.  However, in circumstances where the maternal clinical condition requires treatment with naproxen during the third trimester, discussion with an obstetrician regarding fetal monitoring for oligohydramnios and neonatal monitoring for ductus arteriosus patency is recommended.

Exposure to naproxen at any stage of pregnancy would not usually be regarded as medical grounds for termination of pregnancy.  However, other risk factors may also be present in individual cases which 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 full UKTIS monographs downloaded directly from TOXBASE.org to be sure you are using the most up-to-date version. The summaries of these monographs are openly available on UKTIS.org.

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.