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USE OF NABUMETONE IN PREGNANCY

Date of issue: December 2023, Version: 4

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A corresponding patient information leaflet on USE OF NABUMETONE IN PREGNANCY is available.

Nabumetone is a non-steroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation in rheumatic disease.

The use of NSAIDs in pregnancy has been associated with an increased risk of miscarriage, malformation (including specific defects, such as cardiovascular defects, septal cardiac defects, and orofacial clefts), preterm delivery and fetal growth impairment. However, the available evidence is often conflicting, is confounded, and may have also been influenced by methodological limitations. Causal relationships between NSAID use in pregnancy and these outcomes are therefore considered unproven.

Data regarding the safety of maternal nabumetone use in human pregnancy is limited to a single population-based cohort study which investigated preterm delivery risks following early pregnancy nabumetone exposure. There are no data regarding other pregnancy outcomes, and it is therefore not possible to provide an evidence-based assessment of the fetal risks following gestational exposure.

Exposure to NSAIDs after 20 weeks of gestation has been associated with an increased risk of premature closure of the ductus arteriosus (DA) and oligohydramnios. These effects are thought to be mediated by the inhibitory effect of NSAIDs on prostaglandin production. There are conflicting findings regarding the risks of persistent pulmonary hypertension of the newborn (PPHN) following antenatal use of NSAIDs. Further evidence is required to assess whether this is a risk. Where published data regarding the fetal effects of gestational exposure are unavailable or limited, a possible class effect for these associations should be considered for all NSAIDs.

All NSAIDs should, where possible, be avoided after 20 weeks of pregnancy. In circumstances where the maternal clinical condition requires short-term treatment with nabumetone (such as acute, short-lived pain), treatment should be limited to the shortest duration possible. There is currently no evidence-based guidance about how long use should be restricted for but pragmatic advice is to limit use to no longer than three days. Longer term use, for example for treatment of chronic arthritis, or any use in the third trimester (28 weeks of gestation or beyond), should be avoided. As fetal urine production begins at approximately 10 weeks’ gestational age, UKTIS recommends referral to a Fetal Medicine Unit for monitoring of DA patency and oligohydramnios following prolonged NSAID exposure after the first trimester.

Please refer to the NSAID overview monograph for more information. Other risk factors may also 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. Discussion with UKTIS is recommended for all cases of mefenamic acid exposure in pregnancy.

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 NHS health care professionals who are logged in.

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 UKTIS.org to ensure you are using the most up-to-date version.