USE OF HALOPERIDOL IN PREGNANCY

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(Date of issue: January 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.

A corresponding patient information leaflet on haloperidol use in pregnancy is available at www.medicinesinpregnancy.org.

Summary

Haloperidol is a butyrophenone derivative ‘typical’ antipsychotic used in the treatment of a range of psychotic disorders including schizophrenia, psychoses, mania, agitation, anxiety, and violent or dangerously impulsive behaviour. Haloperidol is also licensed for the treatment of motor tics, intractable hiccups, nausea and vomiting, and Tourette syndrome.

Although haloperidol exposures are included in a number of studies which report fetal outcomes for cohorts of pregnant women exposed to various antipsychotics, the percentage and absolute number of haloperidol exposures in each of these cohorts is generally very small and separate analysis for haloperidol is rarely undertaken. 

The data on which to assess fetal risk of exposure to haloperidol in human pregnancy are mainly derived from published case reports, an uncontrolled case series, a controlled cohort study, and are extremely limited.   

No studies have been published which investigate the risk of spontaneous abortion, stillbirth/IUD or neurodevelopmental impairment following in utero exposure to haloperidol specifically. Although the available data do not suggest that haloperidol use in pregnancy is associated with an increased risk of congenital anomaly or abnormal birth weight, increased risks for these outcomes have been reported for antipsychotics as a group and can therefore not be discounted. Furthermore, data are available which have also suggested increased risks of preterm delivery and neurodevelopmental impairment following typical antipsychotic exposure. However, the possibility of data confounding cannot be excluded.

Adverse neonatal effects including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorders have been reported following maternal haloperidol use in pregnancy. As such, delivery should be planned in a unit with adequate neonatal facilities for the management of PNAS.

It is important to ensure that maternal mental health is treated appropriately. Where a patient is stabilised on haloperidol, 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 haloperidol use during pregnancy with the patient. Where the benefit of continued treatment is considered to outweigh any potential or known risks, haloperidol may be prescribed for use in pregnancy. Where use of haloperidol is clinically indicated in an emergency situation, it should not be withheld on account of pregnancy.

Exposure to haloperidol 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 UKTIS monographs downloaded directly from TOXBASE.org or UKTIS.org to be sure you are using the most up-to-date version.

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.