Fluoxetine

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Date: June 2022, Version 3.1

What is it?

Fluoxetine® is a type of antidepressant drug called an SSRI (selective serotonin reuptake inhibitor). It is used to treat depression, bulimia nervosa, and obsessive-compulsive disorder.

Benefits

What are the benefits of taking fluoxetine?

Fluoxetine can prevent or reduce the unpleasant symptoms that happen with some mental health conditions. This is important for good quality of life and to ensure that a pregnant woman remains well in preparation for caring for her baby.

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

Risks

Are there any risks of taking fluoxetine during pregnancy?

SSRIs are commonly taken during pregnancy without any problem. However, some studies have linked SSRIs to a higher chance of preterm delivery, or of having a baby with a low birth weight. It is unclear whether these effects are due to medication, or whether they are due to underlying illness in the mother and other factors.

In the past, SSRI use in early pregnancy was thought to slightly increase the chance of heart problems with the baby. However, more recent studies generally 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 an SSRI in pregnancy will usually be advised to have a hospital delivery. This is because:

• SSRIs can sometimes 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. As a precaution, the baby will be checked for breathing problems by a midwife or paediatrician.

• Women taking an SSRI 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.

A large number of studies have assessed the learning and behaviour of children exposed in the womb to SSRIs:

• Some studies have suggested that up to three out of every 100 children born to women taking an SSRI may develop autism spectrum disorder (ASD). In comparison, around one in every 100 children in the background population is diagnosed with ASD. Other studies have found no links between SSRI exposure and ASD.

• Some (but not all) studies have found that children exposed in the womb to SSRIs showed differences in their thinking and learning.

• Some (but not all) studies have suggested that SSRI exposure may affect motor skills (movement), at least in the first few weeks of life.

Although some of this information may seem worrying, more research is required before we can say whether any differences in learning and behaviour are linked to SSRI use in pregnancy, to the mother’s underlying condition, or to a combination of both of these factors.

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.

Alternatives

Are there any alternatives to taking fluoxetine?

Possibly. Other medicines can be used to treat mental health conditions, but there is no evidence that any of these are safer for the baby than an SSRI. Some people can be treated with talking therapies instead of medicines. However, this does not work for everyone and sometimes a medicine is preferred. If a woman’s condition is well-controlled with fluoxetine, it may be best to stay on it rather than try something new and risk a relapse.

Ideally, women planning a pregnancy should speak to their GP or specialist to decide whether fluoxetine 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 fluoxetine 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.

Women should not stop taking fluoxetine without first speaking to their 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 fluoxetine use in pregnancy.

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

There is currently no evidence that fluoxetine used by the father can harm the baby through effects on the sperm.

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.

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