USE OF ARIPIPRAZOLE IN PREGNANCY

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(Date of issue: March 2015, Version: 2.1)

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 aripiprazole use in pregnancy is available at www.medicinesinpregnancy.org.

Summary

Aripiprazole is an atypical antipsychotic used in the treatment of schizophrenia, manic episodes, bipolar disorder, and other psychoses.

There are only two small cohort studies which specifically investigate the use of aripiprazole in pregnancy. Although aripiprazole exposures are included in a number of other studies which report on fetal outcome of women exposed to various antipsychotics, aripiprazole exposures generally represent only a small proportion of the study cohort and were not analysed separately.

Human pregnancy data for aripiprazole are thus limited. Although the little data that are available do not suggest an increased risk of congenital malformation or spontaneous abortion, increased risks of low birth weight and preterm delivery have been reported in the single study that assessed these endpoints. Increased risks for some of the above outcomes have been reported for antipsychotics as a group, however, the data are limited and in some cases conflicting, and the relative contribution of the underlying maternal illness and co-exposure to other psychoactive substances remains undefined. As aripiprazole has not been adequately studied, there are currently insufficient data to exclude or quantify risk of adverse pregnancy outcome with use. 

Maternal hyperglycaemia and increased fetal growth have been reported with use of atypical antipsychotics in pregnancy, although an association with impaired fetal growth has also been reported and data are thus conflicting. Given that weight gain is a recognised complication of aripiprazole therapy and that  maternal obesity, pre-pregnancy diabetes and both low and high infant birth weight are associated with increased risk of adverse pregnancy outcome, additional maternal and fetal monitoring may be prudent until more robust data are available.

Use of aripiprazole 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 neonatal intensive care facilities. Increased rates of neonatal complications in general have been reported in the offspring of both medicated and unmedicated women with psychotic illnesses. The relative contribution of the underlying maternal condition and other confounders (e.g. concurrent exposures) has therefore not been clearly defined.

It is important to ensure that maternal mental health is treated appropriately. Where a patient is stabilised on aripiprazole, 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 aripiprazole use during pregnancy with the patient. Where the benefit of continued treatment is considered to outweigh any potential or known risks, aripiprazole may be prescribed for use in pregnancy.

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.