(Date of issue: January 2014. Version: 2a)
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?
Quetiapine (Seroquel®) belongs to a group of medicines called atypical antipsychotics. Quetiapine is used to treat illnesses such as schizophrenia and bipolar disorder.
Is it safe to take quetiapine in pregnancy?
There is no yes or no answer to this question. When deciding whether or not to take quetiapine during pregnancy it is important to weigh up how necessary quetiapine 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 quetiapine in pregnancy may be the best option for both mother and baby.
This leaflet summarises the scientific studies relating to the effects of quetiapine on a baby in the womb. It is advisable to be aware of this information if you are, or will be taking quetiapine during pregnancy.
Your doctor is the best person to help you decide what is right for you and your baby.
What if I have already taken quetiapine 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 medicine 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 quetiapine as this could be dangerous to you, and to your baby if you are already pregnant. Do not make any change to your medication without first talking to your doctor.
Can taking quetiapine 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 studies have specifically investigated whether taking quetiapine during early pregnancy might increase the chance of having a baby with a birth defect.
There are, however, several studies of women taking any type of antipsychotic medicine. Small numbers of the women in these studies were taking quetiapine, but these women were not studied separately. The studies are summarised below:
• Two studies showed that women taking any antipsychotic had a higher chance of having a baby with a birth defect, but five studies found no link between antipsychotic use in early pregnancy and having a baby with a birth defect.
• One study found that around three in every hundred women who took an atypical antipsychotic in pregnancy had a baby with a heart defect compared to one in every hundred women who did not take any medication in pregnancy. No other studies have investigated this and it is therefore not yet clear whether there is a link between atypical antipsychotic use in early pregnancy and heart defects, or whether babies who were exposed to antipsychotics in the womb are more likely to have heart scans that pick up abnormalities that would otherwise not have been known about at birth. Even if it is shown one day that women who take atypical antipsychotics are at increased risk of having a baby with a heart defect, this study suggests that 97 out of every 100 babies born to women taking atypical antipsychotics during pregnancy will not have a heart defect.
Taken together, the results of these studies do not provide firm evidence to link taking antipsychotics during early pregnancy with birth defects in the baby. Although quetiapine is chemically similar to some of the other antipsychotics, it may affect a baby in the womb differently. We therefore do not know whether the findings from studies of antipsychotics as a group relate to women taking quetiapine and it is very important that information continues to be collected from women who take quetiapine in pregnancy.
Can taking quetiapine in pregnancy cause miscarriage?
No studies have specifically investigated whether women who take quetiapine during early pregnancy are at increased risk of miscarriage.
Studies of pregnant women taking different types of antipsychotics have shown mixed results. While two studies found no link between miscarriage and atypical antipsychotic use in pregnancy, one study did suggest an increased risk.
Some of the women in these studies were taking quetiapine but were not studied separately, so we do not know how this information relates specifically to pregnant women taking quetiapine. Additionally, because only small numbers of women have been studied, more information is needed before any conclusions can be drawn.
Can taking quetiapine in pregnancy cause preterm birth, altered birth weight, or stillbirth?
There are no known links between taking quetiapine in pregnancy and giving birth before 37 weeks of pregnancy, having a stillbirth, or the baby being bigger or smaller than expected. However, no studies have specifically investigated these pregnancy outcomes.
Some studies have analysed these pregnancy outcomes in women taking any antipsychotic medicine during pregnancy, with most finding no increased risk.
However, weight gain, high blood sugar and diabetes are common side effects of quetiapine in non-pregnant individuals. If these problems occur in pregnancy they can in turn cause increased growth of a baby in the womb.
Can taking quetiapine in pregnancy cause other health problems in the child?
Withdrawal symptoms at birth (neonatal withdrawal)
Withdrawal symptoms are thought to occur as a result of the newborn baby’s body having to adapt to no longer getting certain types of medicines through the placenta.
Studies have shown that babies whose mothers take antipsychotic medicines (including quetiapine) in the weeks before delivery are more likely to experience neonatal withdrawal symptoms at birth. Close monitoring of your baby for a few days after birth may be advised if you have taken quetiapine 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 links with learning and behavioural problems, such as autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD), are known about in children who were exposed specifically to quetiapine while in the womb, however no studies have been carried out to specifically investigate this.
One study has analysed learning and behaviour in children whose mothers were treated with any antipsychotic medicine during pregnancy. While babies of mothers who had taken antipsychotics during pregnancy were slightly slower in their development initially, by the time they were one year old there were no differences in developmental test scores between children exposed to antipsychotics in the womb and children who had not been exposed.
More research in this area is needed so that the quetiapine can be specifically studied.
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 as part of their routine antenatal care. Taking quetiapine in pregnancy would not normally require extra monitoring of your baby.
Weight gain and increased blood sugar (hyperglycaemia) can be side effects of quetiapine. If you are treated with quetiapine during pregnancy your doctor may suggest extra monitoring of your weight and blood sugar levels. If you are gaining more weight than expected, or have high blood sugar levels, extra monitoring of your baby’s growth may be advised as these can be linked to having a bigger baby.
If you have taken quetiapine around the time of delivery, because of the risk of withdrawal symptoms in the baby, he/she may require extra monitoring after birth.
Are there any risks to my baby if the father has taken quetiapine?
We would not expect any increased risk to your baby if the father took quetiapine 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.