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USE OF SILDENAFIL IN PREGNANCY

Date of issue: January 2024, Version: 2.0

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

Sildenafil is a phosphodiesterase type-5 inhibitor with vasodilatory effects that is most commonly used to treat male erectile dysfunction (commonly sold under the brand name Viagra®). It is also licensed in the UK (brand name Revatio®) to treat pulmonary arterial hypertension (PAH). Several clinical trials have explored the use of sildenafil as a maternally-administered in utero treatment to improve fetal outcomes following detection of severe fetal growth restriction.

Meta-analysis of data from randomised controlled trials (RCTs) to address whether periconceptual exposure to sildenafil improves pregnancy rates following fertility treatment do not suggest any association with implantation failure/early miscarriage (and in some cases suggest improved pregnancy rates). The limited available data do not suggest that sildenafil exposure in later pregnancy is associated with stillbirth, reduced birth weight, or reduced gestational length. Case reports document seven confirmed first trimester exposures, with no infant malformations recorded.

In 2018 an RCT to investigate use of sildenafil to treat severe fetal growth restriction was halted due to a potential safety signal suggesting that exposure to sildenafil in utero could cause persistent pulmonary hypertension of the newborn (PPHN). Subsequent meta-analysis of all available data from this trial as well as data from other similar trials has not identified increased risks of PPHN, neonatal death, or severe neonatal morbidity following sildenafil use in pregnancy. The trials also did not demonstrate a beneficial effect of sildenafil on fetal outcome.

Women with PAH are generally advised against pregnancy due to a high risk of complications (maternal mortality rates of 17% to 50% have been reported). Pregnant women with PAH will therefore require ongoing treatment. Where use of sildenafil is required during pregnancy, the patient should be counselled about the risks and benefits of treatment and the potential risks to the woman and fetus of discontinuing treatment.

Exposure to sildenafil at any stage of pregnancy would not usually be regarded as medical grounds for termination of pregnancy. Close maternal and fetal monitoring and hospital delivery will be indicated due to the maternal condition, as well as the largely unknown effects of the exposure. 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.

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.