(Date of issue: August 2014. Version: 2)
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.
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?
There is no yes or no answer to this question. When deciding whether or not to take haloperidol during pregnancy it is important to weigh up how necessary haloperidol is to your health against the possible risks to you or your baby, some of which will 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 in pregnancy may be necessary.
This leaflet summarises the scientific studies relating to the effects of haloperidol on a baby in the womb. It is advisable to consider this information before taking haloperidol if you are pregnant. Your doctor is the best person to help you decide what is right for you and your baby.
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.
No large studies have specifically investigated the occurrence of birth defects in babies of women who took haloperidol. There are isolated reports of babies born to women who took haloperidol during pregnancy; the vast majority of these did not have birth defects. However, larger numbers of babies need to be studied to confirm this finding
Two studies have shown that babies of women who took any type of antipsychotic medicine are more likely to have a birth defect, but three other studies did not agree with this finding. Although some of the women in these studies were taking haloperidol, they were not studied separately. Haloperidol is chemically similar to some other antipsychotics but it may affect a baby in the womb differently. It is therefore very important that information continues to be collected from women who take haloperidol in pregnancy.
Can taking haloperidol in pregnancy cause miscarriage?
No studies have specifically investigated whether women who take haloperidol during early pregnancy are at increased risk of miscarriage.
No increased risk of miscarriage was seen in either of two studies of pregnant women taking different types of antipsychotics, although one further study of a mixed group of women taking antipsychotics or other medicines to treat depression and anxiety did suggest an increased risk of miscarriage.
Although some of the women in these studies were taking haloperidol, they were not studied separately so we do not know how this information relates specifically to pregnant women taking haloperidol. More information about pregnant women taking haloperidol is needed before any conclusions can be drawn.
Can taking haloperidol in pregnancy cause stillbirth?
No studies have specifically investigated whether women who take haloperidol during early pregnancy are at increased risk of stillbirth.
None of three studies of pregnant women taking any antipsychotic showed an increased risk of stillbirth. However, stillbirth rates need to be studied in pregnant women specifically taking haloperidol before conclusions can be drawn.
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 link with learning and behavioural problems (e.g. autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD)) is known about in children who were exposed specifically to haloperidol while in the womb, however no studies have been carried out to specifically investigate this.
One small study showed that babies of women who took an antipsychotic medicine in pregnancy (including some who had taken haloperidol) tended to score lower in developmental tests than babies not exposed to antipsychotics. The babies were not studied again at a later age, so we do not know if there were any longer term effects. Babies of women taking haloperidol were also not studied separately.
More research in this area is needed so that children who were exposed to haloperidol in the womb can be specifically 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.
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.