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Date of issue: October 2021, Version: 4

Sulpiride is an atypical antipsychotic (AAP) used in the treatment of schizophrenic disorders.

There are no studies which specifically investigate the 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 antipsychotics (APs) as a group, sulpiride exposures represented only a very small proportion of the total study cohort and the outcomes have not been analysed separately. There has been one small controlled prospective study which specifically examined the outcomes of 162 pregnancies following gestational exposure to the s-enantiomer of sulpiride, levosulpiride. This study found no significantly increased risk of miscarriage, major malformation, stillbirth or specific neonatal complications in exposed pregnancies compared to age-matched non-exposed controls. However, this study is statistically underpowered and mainly reports outcomes following short inadvertent exposures early in the first trimester. While data do not currently raise concern of increased risks of adverse pregnancy outcomes, they are currently too limited to exclude such associations.

Studies of APs/AAPs as therapeutic classes that include a collective total of >13,600 exposures do not raise concerns of adverse pregnancy outcomes directly related to use. Although findings relating to stillbirth and preterm delivery rates are conflicting, the studies reporting possible associations for these outcomes may be confounded by concomitant risk factors related to the underlying condition. Further research is therefore required. Neurodevelopmental outcomes following in utero exposure to APs have not been sufficiently studied to permit any further assessment of risk.

In the non-pregnant population, use of AAPs (particularly olanzapine and clozapine) is a risk factor for impaired glucose homeostasis and type 2 diabetes. Theoretical concerns regarding an increased risk of maternal gestational diabetes mellitus (GDM) and its sequelae therefore exist following gestational antipsychotic use. There are no data that investigate risk of GDM with use of sulpiride specifically.

Use of APs throughout pregnancy or near delivery has been associated with withdrawal symptoms in the neonate 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. For all pregnancies with exposure to CNS-acting medication, delivery should be planned in a unit with adequate neonatal facilities.

It is important to ensure that maternal mental health is treated appropriately. Where a woman’s illness 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. Owing to the lack of data regarding malformation risks, women who have been exposed to sulpiride in the first trimester are particularly encouraged to attend their routine detailed fetal anomaly scan, which is generally conducted at around 18 to 20 weeks of 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.

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