(Date of issue: January 2015. 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?
Risperidone (Risperdal®) belongs to a group of medicines called atypical antipsychotics and is used to treat schizophrenia, mania and persistent aggression.
Is it safe to take risperidone in pregnancy?
There is no yes or no answer to this question. When deciding whether or not to take risperidone during pregnancy it is important to weigh up how necessary risperidone 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 risperidone in pregnancy may be necessary.
This leaflet summarises the scientific studies relating to the effects of risperidone on a baby in the womb. It is advisable to consider this information before taking risperidone 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 risperidone 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 risperidone 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 risperidone 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 study of over 250 pregnant women who were treated with risperidone does not suggest that risperidone use in pregnancy increases the risk of birth defects in the baby. A further study that investigated a total of 400 pregnant women taking risperidone (including those in the study already described) also found no increased risk of birth defects. Although this is reassuring, larger numbers of pregnant women taking risperidone need to be studied to confirm these findings.
There are also several studies of pregnant women taking any type of antipsychotic medicine, some of which include a small number of women taking risperidone. The antipsychotic medicines analysed often differ from one study to another and women taking risperidone were generally only a small portion of the study group and were not studied separately. The findings of these studies may therefore not be directly relevant to women taking risperidone but are summarised below for interest:
• Three studies showed that women taking any antipsychotic had an increased chance of having a baby with a birth defect, but two further 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, these studies do not prove that taking antipsychotics during early pregnancy causes birth defects in the baby. Although risperidone 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 risperidone and it is very important that information continues to be collected from women who take risperidone in pregnancy.
Can taking risperidone in pregnancy cause miscarriage?
No studies have specifically investigated whether women who take risperidone during early pregnancy are at increased risk of miscarriage.
No increased risk of miscarriage was seen in any of three 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.
Some of the women in these studies were taking risperidone but were not studied separately so we do not know how this information relates specifically to pregnant women taking risperidone. More information about pregnant women taking risperidone is needed before any conclusions can be drawn.
Can taking risperidone in pregnancy cause stillbirth?
No studies have specifically investigated whether women who take risperidone during early pregnancy are at increased risk of stillbirth.
None of five 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 risperidone before definite conclusions can be drawn.
Can taking risperidone in pregnancy cause preterm birth?
No studies have specifically investigated whether women who take risperidone during early pregnancy are at increased risk of preterm birth.
Some (but not all) studies of pregnant women taking any antipsychotic have shown an increased risk of preterm delivery. Because only small numbers of women specifically taking risperidone have been studied, more information on this subject is needed.
Can taking risperidone in pregnancy affect a baby’s growth in the womb and his/her birth weight?
Low birth weight
No large studies have been carried out to investigate whether risperidone use might affect a baby’s birth weight. There are, however, isolated reports of babies who were exposed to risperidone in the womb being smaller than expected for the stage of pregnancy at which they were born. Four studies of pregnant women taking any antipsychotic have shown an increased risk of low birth weight, but a further two studies have not agreed with this. More information about women specifically taking risperidone therefore needs to be collected.
Increased birth weight
Weight gain, high blood sugar and diabetes are common side effects of risperidone 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, information on risperidone specifically is very limited and further research into the specific effects of risperidone on a baby’s birth weight is required.
Can taking risperidone 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 risperidone 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 risperidone 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 risperidone 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 various antipsychotic medicines (not just risperidone) 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.
One small study showed that six month old babies who had been exposed to any antipsychotic in the womb 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.
More research in this area is needed so that children who were exposed to risperidone 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 and check their baby’s growth as part of their routine antenatal care. Taking risperidone in pregnancy would not normally require extra monitoring of your baby.
Weight gain and increased blood sugar (hyperglycaemia) can be side-effects of risperidone. If you are treated with risperidone 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, which may affect where and when your baby is delivered.
If you have taken risperidone around the time of delivery your baby may require extra monitoring after birth because of the possible risk of neonatal withdrawal. Babies who are large at birth may also need to have their blood sugar monitored for a few days.
Are there any risks to my baby if the father has taken risperidone?
We would not expect any increased risk to your baby if the father took risperidone 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.