USE OF SULPIRIDE IN PREGNANCY

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(Date of issue: January 2017, 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

Sulpiride is an antipsychotic used in the treatment of schizophrenic disorders.

There are no studies which specifically investigate the maternal use of sulpiride during pregnancy. Although sulpiride exposures are included in a small number of studies which report on the fetal outcomes of women exposed to various antipsychotics, sulpiride exposures generally represent only a very small proportion of the total study cohort and the outcomes have not been analysed separately. As such, it is not currently possible to provide an evidence-based assessment of the potential fetal risks posed by maternal sulpiride use during pregnancy.

Increased risks of spontaneous abortion, congenital malformation, intrauterine death, small for gestational age, preterm delivery, neonatal complications and neurodevelopmental impairment have been reported for antipsychotics as a group. However, the available data are generally conflicting and the relative contribution of the underlying maternal illness and co-exposure to other psychoactive substances (therapeutic and/or recreational) may confound these observations.

Use of antipsychotics throughout pregnancy or near delivery has been associated with withdrawal symptoms in the neonate and/or poor neonatal adaptation syndrome (PNAS). These symptoms are likely to be more severe in infants exposed in utero to more than one CNS acting drug. Delivery should be planned in a unit with the necessary neonatal facilities to monitor for and treat PNAS symptoms if required. Increased rates of neonatal complications in general have been reported in the offspring of both medicated and non-medicated women with psychotic illnesses. However, the relative contribution of the underlying maternal condition and other confounding factors has not been clearly defined.

It is important to ensure that maternal mental health is treated appropriately. Where a patient is stabilised on sulpiride, either prior to conception or during pregnancy, the risk of discontinuing or changing medication, or reducing the dose, should be carefully weighed against the risk of relapse of the maternal condition. Where clinically appropriate, clinicians are encouraged to discuss the advantages and disadvantages of continued sulpiride use during pregnancy with the patient. Where the benefit of continued treatment is considered to outweigh any potential or known risks, sulpiride use in pregnancy may be the best option for both mother and baby.

Exposure to sulpiride 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 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.