Clozapine

(Date: October 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.

What is it?

Clozapine (Clozaril®, Denzapine®, Zaponex®) belongs to a group of medicines called atypical antipsychotics and is used to treat schizophrenia and psychosis caused by Parkinson’s disease.

Is it safe to take clozapine in pregnancy?

When deciding whether or not to take clozapine during pregnancy it is important to weigh up the potential benefits to your health and wellbeing against the possible risks to you or your baby, some of which will depend on how many weeks pregnant you are. During pregnancy, psychiatric illness can sometimes occur for the first time, or may get worse. For some women, treatment with an antipsychotic such as clozapine may be offered by a specialist so that they have the best chance of remaining well.

What if I have already taken clozapine 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 clozapine as this could be dangerous. Do not make any changes to your medication without first talking to your doctor.

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

No studies have assessed the chance of birth defects in babies of women who specifically took clozapine in pregnancy.

While studies of over 10,000 women who used any type of antipsychotic during pregnancy do not collectively raise alarm of a link with birth defects, studies of pregnant women taking clozapine are ideally required.

Can taking clozapine in pregnancy cause miscarriage?

No studies have assessed the chance of miscarriage in women who specifically took clozapine in pregnancy.

Studies of around 3,000 women who used any type of antipsychotic during pregnancy do not raise concern of a direct link with miscarriage. While this is reassuring, studies of women specifically taking clozapine are ideally required.

Can taking clozapine in pregnancy cause stillbirth?

No studies have assessed the chance of stillbirth in women who specifically took clozapine in pregnancy.
 
Studies of stillbirth in pregnant women taking any antipsychotic have produced mixed findings, with three studies finding no link but one large study finding a possible link. Further studies of women specifically taking clozapine are required before definite conclusions can be drawn.

Can taking clozapine in pregnancy cause preterm birth?

No studies have assessed the chance of preterm birth in women who specifically took clozapine in pregnancy.

Some (but not all) studies of pregnant women taking any antipsychotic have shown a possible link with preterm delivery, but it is thought that lifestyle factors in pregnant women taking antipsychotics are likely to have contributed to this finding. More information on this subject, including assessment of women specifically taking clozapine, is needed.

Can taking clozapine in pregnancy affect a baby’s growth in the womb (and birth weight)?

Low birth weight
No studies have investigated whether clozapine use in pregnancy might affect a baby’s birth weight. Studies of pregnant women taking any antipsychotic do not overall raise alarm that their use slows the baby’s growth in the womb. Information about women specifically taking clozapine ideally needs to be collected.

Increased birth weight
Weight gain, high blood sugar and diabetes are common side effects of antipsychotic use in non-pregnant individuals. If these problems occur in pregnancy they can in turn cause increased growth of a baby in the womb. Some studies, but not others, have found a possible link between antipsychotic use in pregnancy and having a large baby. However, no studies have yet investigated whether babies born to women specifically taking clozapine are more prone to having a high birth weight.

Can taking clozapine 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 clozapine 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 clozapine regularly in the weeks before delivery. Your doctor may therefore advise that your baby is delivered at a hospital with facilities to provide this care.

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 investigated learning and behaviour in children exposed in the womb to clozapine.

Will I or my baby need extra monitoring?

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

Weight gain and increased blood sugar (hyperglycaemia) can be side effects of clozapine. If you are taking clozapine during pregnancy and are gaining more weight than expected, or have higher than expected levels of sugar in your urine, your doctor may offer you a glucose tolerance test to measure how your body responds to sugar.

If you have taken clozapine 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 clozapine?

We would not expect any increased risk to your baby if the father took clozapine 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.  

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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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