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Date of issue: February 2021, Version: 4

Amisulpride is an atypical antipsychotic used in the treatment of schizophrenic disorders.

There are no studies which specifically investigate the use of amisulpride in pregnancy. Although amisulpride exposures are included in a number of studies that report on fetal outcome of women exposed to various antipsychotics, amisulpride exposures generally represented only a tiny proportion of the study cohort and were not analysed separately.

As amisulpride has not been adequately studied, there are currently insufficient data to exclude or quantify the risk of adverse pregnancy outcome with use during pregnancy. Studies of antipsychotics (APs)/atypical antipsychotics (AAPs) as therapeutic classes, which 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 increased risks for these outcomes were not adequately controlled and further research is therefore required to confirm or refute these associations. Neurodevelopmental outcomes following gestational exposure to APs have not been sufficiently studied to permit any 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. There are therefore concerns of an increased risk of maternal gestational diabetes mellitus (GDM) and its sequelae following gestational AAP use. An increased risk of fetal macrosomia following gestational exposure to AAPs is therefore also possible.

Use of APs 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. 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 patient is stabilised on amisulpride, 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 amisulpride use during pregnancy with the patient. Where the benefit of continued treatment is considered to outweigh any potential or known risks, amisulpride use in pregnancy may be the best option for both mother and baby.

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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