Haloperidol

(Date: January 2019. Version: 3)

This factsheet has been written for members of the public by the UK Teratology Information Service (UKTIS). UKTIS is a not-for-profit organisation funded by Public Health England on behalf of UK Health Departments. UKTIS has been providing scientific information to health care providers since 1983 on the effects that medicines, recreational drugs and chemicals may have on the developing baby during pregnancy.

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What is it?

Haloperidol (Dozic®, Haldol®, Serenace®) is an antipsychotic medicine that is used to treat schizophrenia, mania, psychoses, agitation, anxiety, Tourette’s Syndrome, and tics (involuntary repetitive movements or sounds).

Is it safe to take haloperidol in pregnancy?

This leaflet summarises the scientific studies relating to the effects of haloperidol on a baby in the womb. When considering treatment with haloperidol in pregnancy it is necessary for women and prescribers to weigh up the risks and benefits to both mother and baby of using a medication against those of not taking it. The outcome of this assessment will vary from person to person and will depend on the severity of the mother’s condition and the complications that could arise if treatment is altered. Some of the possible risks to a baby may depend on how many weeks pregnant you are. Remaining well is particularly important during pregnancy and while caring for a baby. For some women, treatment with haloperidol during pregnancy may be considered necessary.

What if I have already taken haloperidol during pregnancy?

If you have taken or are taking any medicines it is always a good idea to let your doctor know that you are pregnant so that you can decide together whether you still need the medicines that you are on and, if so, to make sure that you are taking the lowest dose that works and only for as long as you need to.

It is very important that you do not suddenly stop taking haloperidol as this could be dangerous to you and to your baby if you are already pregnant. Do not make any changes to your medication without first talking to your doctor.

Can taking haloperidol in pregnancy cause birth defects in the baby?

A baby’s body and most internal organs are formed during the first 12 weeks of pregnancy. It is mainly during this time that some medicines are known to cause birth defects.

One small study found no link between use of haloperidol in early pregnancy and birth defects in the baby. Studies of women taking any type of antipsychotic medicine in early pregnancy also do not, overall, provide convincing evidence that these medicines cause birth defects in the baby in general, or heart defects specifically. While these findings provide reassurance, larger numbers of women specifically taking haloperidol in early pregnancy need to be studied to confirm that it does not cause birth defects.

Can taking haloperidol in pregnancy cause miscarriage?

No studies have specifically investigated whether women who take haloperidol during early pregnancy have a higher chance of miscarriage.

Studies of miscarriage in women taking any type of antipsychotic medicine have produced mixed findings, with some (but not all) finding that women taking antipsychotics had a higher chance of miscarriage. However, most of these studies did not account for other factors that may have affected the chance of miscarriage such as smoking, the mother’s illness, and use of other medicines. Further studies that take these factors into account are therefore required.

Can taking haloperidol in pregnancy cause stillbirth?

No studies have specifically investigated whether women who take haloperidol during pregnancy have a higher chance of stillbirth.

Studies of stillbirth in women taking any type of antipsychotic medicine have produced mixed findings. Most found that women taking antipsychotics did not have a higher chance of stillbirth. However, one of the better designed studies to have examined this outcome found that pregnant women taking antipsychotics had double the chance of stillbirth compared to women not taking antipsychotics. If this finding is correct, it still means that at least 99 out of every 100 women taking an antipsychotic will not have a stillbirth. Furthermore, it is unclear how this information relates to women specifically taking haloperidol. Women taking haloperidol in pregnancy should discuss any concerns with their doctor. Altering the dose or stopping the medicine without medical supervision can be dangerous.

Can taking haloperidol in pregnancy cause preterm birth?

No studies have specifically investigated whether women who take haloperidol during early pregnancy are at increased risk of preterm birth (before 37 weeks of pregnancy).

Seven studies of pregnant women taking any antipsychotic have all shown an increased risk of preterm birth compared to women not taking antipsychotics. However, because these studies included only small numbers of women taking haloperidol and they were not investigated separately, more information on this subject is needed.

Can taking haloperidol in pregnancy alter the baby’s birth weight?

Low birth weight
No large studies have been carried out to investigate whether haloperidol use might affect a baby’s birth weight. There are, however, isolated reports of babies who were exposed to haloperidol in the womb being smaller than expected for the stage of pregnancy at which they were born, although the mothers of these babies were taking other medicines and/or had illnesses that might explain the low birth weights. There are also some reports of haloperidol-exposed babies with normal birth weights.

Several studies of pregnant women taking any antipsychotic have been carried out, and overall there is no evidence that their use in pregnancy causes low birth weight in the baby. However, because haloperidol may affect a baby in the womb differently to other antipsychotics, more information about women specifically taking haloperidol needs to be collected.

Increased birth weight
Weight gain, high blood sugar and diabetes are common side effects of some antipsychotics. If these problems occur in pregnancy they can in turn cause increased growth of a baby in the womb. None of the four studies that have investigated increased birth weight found a link between antipsychotic use in pregnancy and having a baby that is larger than expected for the stage of pregnancy. No specific studies of haloperidol have been carried out.

Weight gain is not a commonly reported side effect for haloperidol, but further research into whether haloperidol use in pregnancy might affect a baby’s birth weight is required.

Can taking haloperidol in pregnancy cause other health problems in the child?

Withdrawal symptoms at birth (‘neonatal withdrawal’)
Withdrawal symptoms are thought to occur, as the newborn baby’s body has to adapt to suddenly no longer getting certain types of medicines through the placenta.

Taking haloperidol and other antipsychotics during pregnancy can lead to neonatal withdrawal. Close monitoring of your baby for a few days after birth may therefore be advised if you have taken haloperidol regularly in the weeks before delivery. 

Learning and behavioural problems
A baby’s brain continues to develop right up until the end of pregnancy. It is therefore possible that taking certain medicines at any stage of pregnancy could have a lasting effect on a child’s learning or behaviour.

No studies have assessed learning and behaviour of children specifically exposed in the womb to haloperidol.

Three studies that examined different aspects of learning and behaviour in babies and children exposed in the womb to any type of antipsychotic have produced mixed findings, with some possible effects on learning and behaviour identified. However, further research that accounts for any effect of the mother’s illness and examines children as they get older to see if any differences in learning and behaviour change with age are required. Children who were exposed specifically to haloperidol in the womb also need to be studied.

Will my baby need extra monitoring?

Most women will be offered a scan at around 20 weeks of pregnancy to look for birth defects as part of their routine antenatal care. Taking haloperidol in pregnancy would not normally require extra monitoring of your baby. 

If you have taken haloperidol around the time of delivery your baby may require extra monitoring after birth because of the possible risk of neonatal withdrawal.

Are there any risks to my baby if the father has taken haloperidol?

We would not expect any increased risk to your baby if the father took haloperidol before or around the time you became pregnant.

Who can I talk to if I have questions?

If you have any questions regarding the information in this leaflet please discuss them with your health care provider. They can access more detailed medical and scientific information from www.uktis.org.  

Feedback request 

WE NEED YOUR HELP! Do you have 3 minutes to complete a short, quick and simple 12 question user feedback form about our bumps information leaflets? To have your say on how we can improve our website and the information we provide please visit www.surveymonkey.co.uk/r/uktis-bumps.

General information 

Up to 1 out of every 5 pregnancies ends in a miscarriage, and 1 in 40 babies are born with a birth defect. These are referred to as the background population risks.  They describe the chance of these events happening for any pregnancy before taking factors such as the mother’s health during pregnancy, her lifestyle, medicines she takes and the genetic make up of her and the baby’s father into account.

Medicines use in pregnancy

Most medicines used by the mother will cross the placenta and reach the baby. Sometimes this may have beneficial effects for the baby.  There are, however, some medicines that can harm a baby’s normal development.  How a medicine affects a baby may depend on the stage of pregnancy when the medicine is taken. If you are on regular medication you should discuss these effects with your doctor/health care team before becoming pregnant.

If a new medicine is suggested for you during pregnancy, please ensure the doctor or health care professional treating you is aware of your pregnancy.

When deciding whether or not to use a medicine in pregnancy you need to weigh up how the medicine might improve your and/or your unborn baby’s health against any possible problems that the drug may cause. Our bumps leaflets are written to provide you with a summary of what is known about use of a specific medicine in pregnancy so that you can decide together with your health care provider what is best for you and your baby.   

Every pregnancy is unique. The decision to start, stop, continue or change a prescribed medicine before or during pregnancy should be made in consultation with your health care provider. It is very helpful if you can record all your medication taken in pregnancy in your hand held maternity records.

   

www.medicinesinpregnancy.org

Disclaimer: This information is not intended to replace the individual care and advice of your health care provider. New information is continually becoming available. Whilst every effort will be made to ensure that this information is accurate and up to date at the time of publication, we cannot cover every eventuality and the information providers cannot be held responsible for any adverse outcomes following decisions made on the basis of this information. We strongly advise that printouts should NOT be kept for any length of time, or for “future reference” as they can rapidly become out of date.

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