USE OF NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDs) IN PREGNANCY

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(Date of issue: May 2019, 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.

Summary

Non-steroidal anti-inflammatory drugs (NSAIDs) are used to treat pain and inflammation in various disease states.

Individual studies have associated NSAID use in early pregnancy with increased risks of congenital malformation overall and other more specific anomalies including cardiovascular defects, septal cardiac defects and orofacial clefts. As these studies are isolated, and there are currently no published studies which corroborate these findings, it is difficult to draw firm conclusions regarding these associations.

A number of studies have demonstrated an association between NSAID exposure and an increased risk of miscarriage. However, these study findings are also likely to be influenced by data confounding and no definitive conclusion has yet been reached. The available data on NSAID use in pregnancy do not suggest an association with stillbirth, low infant birth weight or preterm delivery.

Exposure to NSAIDs after 30 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 an increased risk of persistent pulmonary hypertension of the newborn (PPHN) following antenatal use of NSAIDs. Further evidence is required. A potential class effect for these associations should be considered for all NSAIDS where published data concerning the fetal effects of gestational exposure to a specific NSAID are unavailable.

All NSAIDs should, where possible, be avoided during the third trimester. If their use cannot be avoided it is recommended that the lowest effective dose is used for the shortest period only. In circumstances where the maternal clinical condition requires treatment with NSAIDs during the third trimester, discussion with a Fetal Medicine Unit regarding antenatal monitoring for oligohydramnios and ductus arteriosus patency is recommended. Where use of an NSAID is being considered at any stage of pregnancy the available pregnancy data should be discussed with the patient to support informed decision-making regarding the risks and benefits of treatment.

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 NSAID exposure in pregnancy.

For information on specific NSAIDs please refer to the appropriate monograph, where available.

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.