Vortioxetine

(Date: May 2022. Version: 1)

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?

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.

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 allows women with a current or previous pregnancy to create a digitally secure ‘my bumps record’. You will be asked to enter information about your health, whether or not you take any medicines, and your pregnancy outcome. 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 https://www.medicinesinpregnancy.org/Login/ to register.

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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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