Use of tricyclic antidepressants in pregnancy

(Date: July 2019. 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.

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What are they?

Tricyclic antidepressants (TCAs) include the medicines amitriptyline, clomipramine, dosulepin (Thaden®), doxepin (Sinepin®), imipramine, lofepramine, nortriptyline and trimipramine.  They are used to treat depression, anxiety, and certain types of nerve pain.

There is a separate bump leaflet on Use of amitriptyline in pregnancy.

Is it safe to take a TCA in pregnancy?

When deciding whether or not to take a tricyclic antidepressant during pregnancy it is important to weigh up how necessary this treatment 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 whilst caring for a baby. For some pregnant women treatment with a TCA may therefore be considered necessary, for example where no other treatment is available or suitable.

This leaflet summarises the scientific studies relating to the effects of tricyclic antidepressants on a baby in the womb. It is advisable to consider this information if you are taking a TCA and are pregnant or could become pregnant in the future.

Your doctor is the best person to help you decide what is right for you and your baby.

What if I have already taken a TCA during pregnancy?

If you have taken 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 to make sure that you are taking the lowest dose that works.

It is very important that you do not suddenly stop taking a tricyclic antidepressant 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 a TCA in pregnancy cause birth defects in my 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. There is mixed scientific evidence about whether taking a TCA during the first trimester of pregnancy may increase the chance of having a baby with a birth defect.

Studies of almost 10,000 pregnant women taking any TCA in the first trimester of pregnancy did not show overall that this increases the chance of the baby having any birth defect, or of heart defects specifically. However, a study of around 1,000 women taking clomipramine during early pregnancy found possible links with heart defects in the baby. Much larger studies need to be carried out to confirm these findings and future research should also take into account the possible effects of underlying illness in the mother on the chance of birth defects in the baby. There is currently no information on the possible effects of use in pregnancy of other specific TCAs.

Can taking a TCA in pregnancy cause miscarriage?

Three studies have investigated a possible link between miscarriage and use of any TCA in pregnancy. Two studies found a possible link while the third did not. It is unclear whether any possible link may be due to an effect of TCAs themselves, or whether underlying maternal ill health may also contribute. Further well-designed studies are required to answer this question, and to assess the chance of miscarriage in women taking specific TCAs.

Can taking a TCA in pregnancy cause stillbirth?

No studies have specifically assessed the chance of stillbirth following use of TCAs in pregnancy. However, a single study of around 4,000 pregnant women taking any TCA showed that their babies did not have a higher chance of dying either just before or just after delivery than babies born to women not taking TCAs. Research into the chance of stillbirth and the possible effects of specific TCAs is required.

Can taking a TCA in pregnancy cause preterm birth, or my baby to be small at birth (low birth weight)?

Six studies of women taking any TCA in pregnancy do not show overall that causes low birth weight in the baby. However, a number of studies have found a possible link between use of TCAs in pregnancy and preterm birth. It is unclear whether this may be due to an effect of TCAs themselves, underlying maternal ill health, or a combination of these factors. More research is required to answer these questions, and to investigate the potential effects of specific TCAs.

Can taking a TCA 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 no longer getting certain types of medicines through the placenta. Exposure to TCAs during pregnancy can cause neonatal withdrawal. Therefore, close monitoring of your baby for a few days after birth may be advised if you have taken a TCA 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.

Small studies of general learning and development in children up to the age of 7 years who were exposed to a TCA in the womb have not shown any adverse effects. However, a single study found a possible link between TCA exposure in the womb and attention-deficit hyperactivity disorder in children, which requires confirmation with further research. Two studies of the chance of autism following exposure to a TCA in the womb produced different findings. While one found no increased chance of autism in exposed children, a second showed an increase, but found that this may be linked to depression in the mother rather than an effect of a specific medicine. A single study of children exposed to specific TCAs found no links between childhood autism and exposure to nortriptyline, but found a possible link with clomipramine exposure.

Further well-designed studies that take into account the possible effects of the mother’s underlying ill health are required to determine whether exposure to TCAs in the womb can affect learning and behaviour.

Will 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 a TCA in pregnancy would not be expected to cause problems that require extra monitoring of your baby.

If you have taken a TCA around the time of delivery your baby may require extra monitoring after birth because of the possible risk of neonatal withdrawal symptoms.

Are there any risks to my baby if the father has taken a TCA?

We would not expect any increased risk to your baby if the father took a TCA 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 healthcare provider. They can access more detailed medical and scientific information from www.uktis.org

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WE NEED YOUR HELP! Do you have 3 minutes to complete a short, quick and simple 12 question user feedback form about our bumps information leaflets? To have your say on how we can improve our website and the information we provide please visit www.surveymonkey.co.uk/r/uktis-bumps.

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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