Aripiprazole

(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.

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What is it?

Aripiprazole (Abilify®) belongs to a group of medicines called atypical antipsychotics and is used to treat schizophrenia, mania, and bipolar disorder.

Is it safe to take aripiprazole in pregnancy?

When deciding whether or not to take aripiprazole 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 aripiprazole may be offered by a specialist so that they have the best chance of remaining well.

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

Can taking aripiprazole 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.

A total of around 2,000 pregnant women taking aripiprazole have been studied. There is currently no suggestion of any link between aripiprazole use in pregnancy and birth defects in general, or heart defects specifically in the baby.

Studies of over 10,000 women who used any type of antipsychotic during pregnancy also do not collectively raise alarm of a link with birth defects.

Can taking aripiprazole in pregnancy cause miscarriage?

Studies of a total of 188 women who took aripiprazole in pregnancy do not collectively raise alarm that they have a higher chance of miscarriage compared to women not taking aripiprazole.

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

Can taking aripiprazole in pregnancy cause stillbirth?

No studies have investigated the chance of stillbirth in women specifically taking aripiprazole 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 aripiprazole are required before definite conclusions can be drawn.

Can taking aripiprazole in pregnancy cause preterm birth?

One small study of 86 women who had taken aripiprazole in pregnancy found that they had a higher chance of preterm delivery compared to women not taking aripiprazole.

Some (but not all) studies of pregnant women taking any antipsychotic have also 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. Because there is only one study of women specifically taking aripiprazole, more information on this subject is needed.

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

Low birth weight
One small study of 86 babies born to women who had taken aripiprazole in pregnancy found that they were three times more likely to have a birth weight lower than expected for the stage of pregnancy than babies born to unexposed women.

Studies of pregnant women taking any antipsychotic do not overall raise alarm that their use slows the baby’s growth in the womb. Further information about women specifically taking aripiprazole 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 aripiprazole are more prone to having a high birth weight.

Can taking aripiprazole 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 aripiprazole 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 aripiprazole 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 aripiprazole.

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 aripiprazole in pregnancy would not normally require extra monitoring of your baby. 

Weight gain and increased blood sugar (hyperglycaemia) can be side effects of aripiprazole. If you are taking aripiprazole 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 aripiprazole 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 aripiprazole?

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