Use of agomelatine in pregnancy

(Date: October 2017. 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 is it?

Agomelatine is an antidepressant medicine.

Is it safe to use agomelatine in pregnancy?

When deciding whether or not to take agomelatine during pregnancy it is important to weigh up how necessary this 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. Your doctor is the best person to help you decide what is right for you and your baby.

No studies have assessed the safety of agomelatine use in pregnancy and so any adverse effects are unknown. Some women with depression may require continued treatment with antidepressant medicines during pregnancy to ensure that they remain well throughout and once they have had their baby. Discussion should take place with a doctor or specialist about the possible risks and benefits to both mother and baby of coming off a medicine, switching to a different medicine, or staying on the same medicine. Untreated depression has been linked to adverse pregnancy outcomes in some studies and this should be borne in mind when deciding whether to continue antidepressant treatment in pregnancy. For some women whose depression was stabilised on agomelatine before pregnancy it may be decided that continuing to take agomelatine during pregnancy poses less of a risk to the mother and baby than changing or stopping treatment.

What if I have already taken agomelatine during pregnancy?

If you are pregnant and have taken any medicines it is always a good idea to let your doctor know in case you need any additional monitoring or treatment.

Can taking agomelatine in pregnancy cause miscarriage, stillbirth, or my baby to be born with birth defects?

No studies have investigated the chance of these pregnancy outcomes in women taking agomelatine and research is therefore required.

A baby’s body and most internal organs are formed during the first 12 weeks of pregnancy. Agomelatine taken after this stage of pregnancy would therefore not cause structural birth defects in the baby.

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

No studies have investigated the chance of these pregnancy outcomes in women taking agomelatine and research is therefore required.

Can taking agomelatine in pregnancy cause learning or behavioural problems in the child?

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.

No studies have investigated learning and behaviour in children exposed in the womb to agomelatine and research is therefore required. Some studies have, however, found that children born to women with depression have a higher chance of learning and behavioural problems, and it has been suggested that this may be at least partly due to the effect that depression may have on the way that women are able to interact with their babies and children.

Will my baby need extra monitoring during pregnancy/after delivery?

As part of their routine antenatal care most women will be offered a scan at around 20 weeks of pregnancy to look for birth defects and to check the baby’s growth.

The effects of agomelatine use during pregnancy are unknown. Women who have taken agomelatine during pregnancy may therefore receive extra monitoring to ensure that the baby is growing and developing as expected.

Exposure in the womb to medicines that are similar to agomelatine can cause withdrawal symptoms in the baby after birth. Women who are taking agomelatine around the time of delivery may therefore be advised to have their baby at a hospital where there are facilities to monitor the baby for withdrawal symptoms and provide treatment if necessary.

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

We would not expect any increased risk to your baby if the father took agomelatine 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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