(Date of issue: June 2014. 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.
What is it?
Amitriptyline (Triptafen®) is a type of antidepressant called a tricyclic antidepressant (TCA). Amitriptyline is also used to treat migraine and certain types of nerve pain.
Is it safe to take amitriptyline in pregnancy?
There is no yes or no answer to this question. When deciding whether or not to take amitriptyline during pregnancy it is important to weigh up how necessary amitriptyline 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. Remaining well is particularly important during pregnancy and while caring for a baby. For some women treatment with amitriptyline in pregnancy may be necessary.
This leaflet summarises the scientific studies relating to the effects of amitriptyline on a baby in the womb. It is advisable to consider this information before taking amitriptyline if you are pregnant. Your doctor is the best person to help you decide what is right for you and your baby.
What if I have already taken amitriptyline during pregnancy?
If you have taken or are taking 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, if so, to make sure that you are taking the lowest dose that works and only for as long as you need to.
It is very important that you do not suddenly stop taking amitriptyline 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 amitriptyline in pregnancy cause birth defects in the 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.
No studies have specifically investigated the occurrence of birth defects in babies of women who took amitriptyline.
However, two studies have looked at whether women who took any type of tricyclic antidepressant (TCA) had a higher chance of having a baby with a birth defect.
The largest study found that heart malformations were slightly more common in babies of women who had taken a TCA during pregnancy. The second, smaller study did not show a link between taking a TCA in pregnancy and having a baby with a heart defect.
There is therefore no firm evidence to link taking TCAs during early pregnancy with heart defects in the baby. Although TCAs are all chemically similar, different TCAs might affect a baby in the womb differently. We therefore do not know whether the findings from studies of TCAs as a group relate to women taking amitriptyline. More research is needed to specifically assess these risks for amitriptyline use in pregnancy.
Can taking amitriptyline in pregnancy cause miscarriage, stillbirth, preterm birth, or my baby to be small at birth (low birth weight)?
No links between amitriptyline use in pregnancy and miscarriage, stillbirth, preterm birth (before 37 weeks of pregnancy), or low birth weight (<2500g) are known about, however no scientific studies have been carried out that have specifically investigated these pregnancy outcomes.
Studies of women taking any type of TCA during pregnancy have not shown any links with preterm birth or low infant birth weight. We do not know how this relates specifically to women taking amitriptyline during pregnancy and more research is required.
Can taking amitriptyline 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.
Although neonatal withdrawal has not been studied for amitriptyline specifically, taking other TCAs during pregnancy is known to cause neonatal withdrawal. Therefore, close monitoring of your baby for a few days after birth may be advised if you have taken amitriptyline regularly in the weeks before delivery.
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.
No link with learning and behavioural problems (e.g. autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD)) is known about in children who were exposed specifically to amitriptyline while in the womb, however no studies have been carried out to specifically investigate this.
Studies of groups of children exposed to any type of TCA while in the womb have not shown a link with learning and behavioural problems, however only very small numbers of children have been studied.
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 amitriptyline in pregnancy would not normally require extra monitoring of your baby.
If you have taken amitriptyline 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 amitriptyline?
We would not expect any increased risk to your baby if the father took amitriptyline 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.
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.