Duloxetine

(Date: March 2018. Version: 3)

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?

Duloxetine (Cymbalta®, Yentreve®) belongs to a group of antidepressants called serotonin noradrenaline reuptake inhibitors (SNRIs) that alter the levels of the ‘mood chemicals’ serotonin and noradrenaline. Duloxetine is used to treat depression, anxiety, nerve pain in diabetic patients, and urinary incontinence.

Is it safe to take duloxetine in pregnancy?

This leaflet summarises the scientific studies relating to the effects of duloxetine on a baby in the womb. When considering treatment with duloxetine in pregnancy it is necessary for women and prescribers to weigh up the risks and benefits to both mother and baby of using a medication against those of not taking it. The outcome of this assessment will vary from person to person and will depend on the severity of the mother’s condition and the complications that could arise if her treatment is altered. Some of the possible risks to a baby may depend on how many weeks pregnant you are. Remaining well is particularly important during pregnancy and while caring for a baby. For some women, treatment with duloxetine during pregnancy may be considered necessary.

What if I have already taken duloxetine 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 duloxetine 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 duloxetine 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.

The chance of birth defects has been studied in around 660 babies born to women who took duloxetine during pregnancy. There is currently no evidence that women taking duloxetine in pregnancy have a higher chance of having a baby with a birth defect compared to women not taking duloxetine but, to confirm this, more information about pregnant women taking duloxetine needs to be collected.

Can taking duloxetine in pregnancy cause miscarriage or stillbirth?

While one study suggested that women who took duloxetine during early pregnancy were about twice as likely to have a miscarriage as women not taking duloxetine, one further study found that the chances of both miscarriage and stillbirth in pregnant women taking duloxetine were similar to those in the background population. Neither of these studies used accurate statistical techniques to investigate miscarriage or were able to account for other factors in the mothers that may have also influenced the chance of miscarriage and stillbirth, such as illness or exposure to other medicines. Further well-designed studies are therefore required to determine whether use of duloxetine in pregnancy might increase the chance of miscarriage or stillbirth.

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

More research is needed before we can say whether duloxetine use in pregnancy may be linked to preterm birth (before 37 weeks) or to having a low birth weight baby (<2,500g). The one study which has investigated this did not show that women taking duloxetine during pregnancy are at increased risk of preterm birth, but more information needs to be collected to confirm this finding. No studies have yet investigated whether women who take duloxetine during pregnancy are more likely to have a low birth weight baby (<2,500g).

Can taking duloxetine 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.

No scientific studies have specifically examined whether duloxetine use in pregnancy may cause withdrawal problems in the baby after birth. However, studies have shown that other medicines that are chemically similar to duloxetine may cause neonatal withdrawal. Close monitoring of your baby for a few days after birth may therefore be advised if you have taken duloxetine regularly in the weeks before delivery.

Persistent pulmonary hypertension of the newborn (PPHN)
Persistent pulmonary hypertension of the newborn (PPHN) occurs when a newborn baby’s lungs do not adapt to breathing outside the womb. PPHN only affects around 1 or 2 out of every 1,000 newborn babies in the general population, but can be serious. PPHN appears to be more common in babies of women who take SSRIs (antidepressants that are chemically similar to duloxetine). Some studies suggest that about 1 out every 100 babies born to mothers who took SSRIs in pregnancy will have PPHN.

Although there are currently no reports of PPHN in babies of pregnant women who took duloxetine, this may be because duloxetine is not commonly used in pregnancy. Therefore, if you have taken duloxetine after 20 weeks of pregnancy your doctor may still advise that your baby is born in a unit with neonatal intensive care facilities in case monitoring or treatment for PPHN is required.

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.

There is no known link between taking duloxetine in pregnancy and learning or behavioural problems in the child later on in life. There are, however, no scientific studies that have specifically investigated a link with these problems.

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 duloxetine in pregnancy would not normally require extra monitoring of your baby.

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

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

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

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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