(Date of issue: August 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?
Sertraline (Lustral®) belongs to a group of antidepressants called Selective Serotonin Reuptake Inhibitors (SSRIs) that alter the levels of a chemical in the brain called serotonin. Sertraline is used to treat depression, obsessive-compulsive disorder, post-traumatic stress disorder, anxiety disorders, and panic disorder.
Is it ‘safe’ to take sertraline in pregnancy?
There is no ‘yes’ or ‘no’ answer to this question. When deciding whether or not to take sertraline during pregnancy it is important to weigh up how necessary sertraline 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 sertraline in pregnancy may be necessary.
This leaflet summarises the scientific studies relating to the effects of sertraline on a baby in the womb. It is advisable to consider this information before taking sertraline 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 sertraline 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 sertraline as this could be dangerous to you, and also to your unborn baby if you are already pregnant. Do not make any change to your medication without first talking to your doctor.
Can taking sertraline 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.
It is not yet clear whether taking sertraline during early pregnancy increases the chance of having a baby with a heart defect. It is known that about one in every 100 babies is born with a heart defect, regardless of whether their mother took any medicines during pregnancy. This is called the “background population risk”. Although most of the studies carried out have shown no link between taking sertraline in early pregnancy and having a baby with a heart defect, some studies have shown a slightly increased risk. However, the available information suggests that even if taking sertraline during early pregnancy does increase the risk of having a baby with a heart defect, the vast majority of women who take sertraline will have a baby with a normal heart.
Heart defects have also been shown to occur slightly more frequently in babies of mothers who took SSRIs other than sertraline in the first trimester of pregnancy. Although this may be because all SSRIs affect some babies’ heart development in a similar way, it is also possible that there is another reason not directly related to SSRIs that explains why babies of women who take SSRIs in pregnancy are more likely to be diagnosed with a heart defect. For example, babies who were exposed to an SSRI in the womb may be more likely to have their heart checked than babies of women who did not use SSRIs. This could result in small heart defects that would otherwise go unnoticed and not cause any problem to the baby’s health being recorded in one group of babies but not in the other group.
Other birth defects
A number of studies have suggested possible links between taking sertraline in early pregnancy and other specific birth defects (malformations). However, these studies (detailed below) do not provide enough evidence to prove that sertraline causes any of these birth defects:
• One study suggested that use of sertraline during pregnancy was linked to having a baby with a neural tube defect called anencephaly (a fatal defect of the brain and skull). No other studies have investigated any possible link between sertraline use in pregnancy and anencephaly and it is therefore not possible to say that there is a link based on only one study.
• One study indicated that sertraline use in early pregnancy may be linked to having a baby with anal atresia (where the anus has not developed), limb reduction defects (where the limbs are shortened or missing), and omphalocoele (where part of the baby’s bowel and sometimes other organs protrude outside of the baby’s body through a gap in the navel). For each of these findings, at least one further study has not agreed that there is an increased risk.
• One study suggested a possible link between sertraline use in early pregnancy and defects of the respiratory (breathing) system. A further three studies have not agreed with this finding.
More research is needed to assess whether taking sertraline in pregnancy increases the chance of birth defects in the baby.
Can taking sertraline in pregnancy cause miscarriage?
No increased risk of miscarriage in women taking sertraline during early pregnancy was shown in either of the two studies that have looked at this. However, because only small number of women have been studied, more research is required before we can say whether or not taking sertraline during early pregnancy increases the chance of miscarriage.
Can taking sertraline in pregnancy cause preterm birth or my baby to be small at birth (low birth weight)?
One study has shown that women taking sertraline during pregnancy were more likely to give birth early (before 37 weeks of pregnancy) and to have a low birth weight baby (<2500g). It is unclear whether the increased risk of having a low birth weight baby was just because the babies were more likely to be born earlier, or whether sertraline might affect a baby’s growth in the womb.
Although a number of studies of women taking any SSRI during pregnancy have shown links with preterm birth, we do not know how this relates to women specifically taking sertraline. It is also thought that other factors, including other medicines used by the mother and the effect of the medical conditions that women were taking SSRIs to treat, may explain why more of these women gave birth early. It is therefore still not clear whether SSRI use in pregnancy causes preterm birth.
Most studies which have analysed information from pregnant women taking any SSRI do not show a link with having a smaller baby. It is not yet clear whether sertraline affects a baby’s growth in the womb and more research into this subject is required.
Can taking sertraline in pregnancy cause stillbirth?
No increased risk of stillbirth was seen in either of the two studies which investigated this. However because only small numbers of women have been studied, more information needs to be collected on this subject.
Can taking sertraline 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 suddenly no longer getting certain types of medicines through the placenta.
Studies have shown that babies who were exposed to any SSRI in the womb may experience neonatal withdrawal. Close monitoring of your baby for a few days after birth may be advised if you have taken fluoxetine regularly in the weeks before delivery.
Persistant Pulmonary Hypertension of the Newborn (PPHN)
PPHN or ‘persistent pulmonary hypertension of the newborn’ occurs when a newborn baby’s lungs do not adapt to breathing outside the womb. PPHN only affects around 1 or 2 out of every 1000 newborn babies but can be serious.
Some studies show that PPHN is more common in babies of women who took an SSRI in pregnancy. These studies suggest that around one out of every 100-200 babies whose mothers took an SSRI during later pregnancy (after 20 weeks) may develop PPHN. In other words, these studies show that 99 out of 100 babies of women who use SSRIs did not develop PPHN.
PPHN has also been shown to be slightly more common in babies whose mothers took SSRIs before 20 weeks of pregnancy and then stopped, but the risk of PPHN does not appear to be as high as when SSRIs are taken after 20 weeks.
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.
Because SSRIs alter levels of certain chemicals in the brain, there are concerns that use in pregnancy may affect the baby’s brain development. A number of studies have been carried out to look at whether there is an increased risk of learning and behavioural problems including autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD) in children who were exposed to SSRIs while in the womb.
There are no scientific studies that have examined learning and behaviour in children of women who specifically took sertraline during pregnancy.
However, many studies have looked at the development, behaviour, and learning of groups of children whose mothers took any of the SSRIs during pregnancy. These studies are summarised below:
• Autism spectrum disorder (ASD) - Five studies have investigated whether taking SSRIs during pregnancy is linked to having a child with ASD. Two of these studies found no convincing link. The other three found that the chance of having a child with ASD was approximately doubled in women who took an SSRI during pregnancy. It is important to remember that around one in every 100 children develop ASD, regardless of whether their mother took any medicines in pregnancy. This is called the ‘background population risk’. These studies suggest that 2-3 out of every 100 children exposed to SSRIs in the womb may develop ASD. In other words, 97-98 out of every 100 children of women who took SSRIs in pregnancy will not have ASD.
• Attention defecit hyperactivity disorder (ADHD) - One large study has not shown a link between use of SSRIs in pregnancy and ADHD in the child. Because only one study has examined this, more research is required.
• Learning and thinking skills - Six studies compared learning and thinking skills of children who were exposed to SSRIs in the womb with children not exposed to SSRIs. While four of these studies showed no clear differences, two studies did see some differences. However, studies of learning and thinking skills in children are very difficult to carry out and may not produce reliable results if too few children are studied. More research is needed before we can say whether children exposed to SSRIs in the womb may be more likely to have problems with learning and thinking skills.
• Movement problems - Nine studies have investigated whether children who were exposed to SSRIs in the womb have different ‘motor development’ (as a result of affects on the way that the brain controls movement) than children not exposed to SSRIs. Six of these studies showed that the motor development of children whose mothers had taken SSRIs during pregnancy was slightly poorer. However, in many of these studies, the children were only observed for the first few weeks of life, so we do not know whether any differences remain as the children get older. More research is required into motor development in children whose mothers were taking SSRIs during pregnancy.
Scientific studies have also suggested that having untreated depression during pregnancy may increase the risk of learning and behavioural problems, including ASD, and lower IQ, in the child. This is thought to be a result of the effects that depression may have on how a mother is able to interact with her baby. Much more research is therefore required before we can say whether the differences in learning and behaviour described in some of these studies are linked to the SSRI use in pregnancy, to the mother’s illness, or to a combination of both these (or other) factors.
Will my baby need extra monitoring during pregnancy?
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 sertraline in pregnancy would not normally require extra monitoring of your baby.
Are there any risks to my baby if the father has taken sertraline?
We would not expect any increased risk to your baby if its father took sertraline before, or at 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.