Date: May 2022, Version 1

What is it?

Vortioxetine is used to treat depression. It works in a similar way to a group of drugs called SSRIs (selective serotonin reuptake inhibitors).


What are the benefits of taking vortioxetine?

Vortioxetine can prevent or reduce the unpleasant symptoms of depression. This is important for good quality of life and to ensure that a pregnant woman remains well in preparation for caring for her baby. Untreated depression in pregnancy has been linked to differences in the child’s learning and behaviour. It is important that pregnant women with mental health conditions like depression are treated for their own and their baby’s wellbeing.


Are there any risks of taking vortioxetine during pregnancy?

Vortioxetine is quite a new drug and its use in pregnancy has not been well-studied. There is no evidence to suggest that it can harm the baby, but ongoing data collection is ideally required.

Vortioxetine is related to a group of drugs called SSRIs and so may have similar effects on the baby. SSRIs are commonly taken during pregnancy. While some studies have shown that SSRI use in pregnancy may slightly increase the chance of heart problems in the baby, other studies do not support this. Even if there is a small effect, it is clear that most women taking an SSRI will have a baby with a normal heart.

Women taking vortioxetine in pregnancy will usually be advised to have a hospital delivery. This is because:

• Drugs like vortioxetine can sometime cause short-term withdrawal symptoms in the newborn baby. Observation of the baby for a short while after birth may be needed.

• Rarely, SSRI use in pregnancy can cause a problem in the baby where blood flow to the lungs is too high. This is called persistent pulmonary hypertension of the newborn (PPHN). Around one in every 300 babies whose mother takes an SSRI may develop PPHN. Because vortioxetine is similar to SSRIs, as a precaution, the baby will be checked for breathing problems by a midwife or paediatrician.

• Women taking vortioxetine in the month before delivery may have a slightly higher risk of post-partum haemorrhage (abnormal blood loss following birth). A hospital delivery ensures that if this occurs it can be treated quickly.


Are there any alternatives to taking vortioxetine?

Possibly. Other medicines can be used to treat mental health conditions. However, if a woman’s condition is well-controlled with vortioxetine, it may be best to stay on it rather than try something new and risk a relapse.

Some people can be treated with talking therapies instead of medicines. However, this does not work for everyone and some may prefer to take a medicine.

Ideally, women planning a pregnancy should speak to their GP or specialist to decide whether vortioxetine is still the best option for them.

No treatment

What if I prefer not to take medicines during pregnancy?

It is very important that mental health conditions are treated to ensure a woman’s wellbeing during pregnancy and while looking after her baby. Stopping vortioxetine can increase the risk of relapse and stopping suddenly can cause withdrawal symptoms. A doctor will only prescribe medicines when necessary and will be happy to discuss any concerns.

Please do not stop taking vortioxetine without first speaking to your midwife, GP or specialist.

Will my baby need extra monitoring?

All pregnant women in the UK are offered a very detailed anomaly scan at around 20 weeks of pregnancy as part of routine antenatal care. No extra monitoring for major birth defects is required following vortioxetine use in pregnancy.

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

We would not expect any increased risk to your baby if the father takes vortioxetine.

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.

How can I help to improve drug safety information for pregnant women in the future?

Our online reporting system (MyBump Portal) allows women who are currently pregnant to create a secure record of their pregnancy, collected through a series of questionnaires. You will be asked to enter information about your health, whether or not you take any medicines, your pregnancy outcome and your child's development. You can update your details at any time during pregnancy or afterwards. This information will help us better understand how medicines affect the health of pregnant women and their babies. Please visit the MyBump Portal to register.

General information
Sadly, miscarriage and birth defects can occur in any pregnancy.

Miscarriage occurs in about 1 in every 5 pregnancies, and 1 in every 40 babies are born with a birth defect. This is called the ‘background risk’ and happens whether medication is taken or not.

Most medicines cross the placenta and reach the baby. For many medications this is not a problem. However, some medicines can affect a baby’s growth and development.

If you take regular medication and are planning to conceive, you should discuss whether your medicine is safe to continue with your doctor/health care team before becoming pregnant. If you have an unplanned pregnancy while taking a medicine, you should tell your doctor as soon as possible.

If a new medicine is suggested for you during pregnancy, please make sure that the person prescribing it knows that you are pregnant. If you have any concerns about a medicine, you can check with your doctor, midwife or pharmacist.

Our Bumps information leaflets provide information about the effects of medicines in pregnancy so that you can decide, together with your healthcare provider, what is best for you and your baby.