(Date of issue: March 2015. 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?
Ursodeoxycholic acid (UDCA) (Destolit®, Urdox®, Ursofalk®, Ursogal®) is a medicine used to treat gallstones and a rare liver condition called primary biliary cirrhosis. UDCA is also used to treat obstetric cholestasis (OC), a liver condition that occurs specifically in pregnancy. For more information on OC, please read the bumps leaflet ‘obstetric cholestasis’.
Is it safe to take UDCA in pregnancy?
There is no yes or no answer to this question. When deciding whether or not to take UDCA during pregnancy it is important to weigh up the benefits of its use against the known or possible risks, some of which will depend on how many weeks pregnant you are.
This leaflet summarises the scientific studies relating to the effects of UDCA on a baby in the womb. It is advisable to consider this information before taking UDCA 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 UDCA 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.
Can taking UDCA in pregnancy cause my baby to be born with birth defects?
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. Use of UDCA after the first trimester would therefore not be expected to cause structural defects in the baby.
UDCA is mainly used in pregnant women to treat obstetric cholestasis, which usually develops in the third trimester. There are therefore no large studies of women who took UDCA in early pregnancy. Case studies in scientific journals describe around 10 pregnant women who took UDCA during the first trimester. All of the babies of these women were born without birth defects. However, although this is useful information, until many more women taking UDCA in early pregnancy are studied, it is not possible to say for certain that UDCA use in the first trimester does not cause birth defects.
Can taking UDCA in pregnancy cause miscarriage?
UDCA is generally used to treat obstetric cholestasis which usually occurs in late pregnancy, by which time the risk of miscarriage (generally classified as a pregnancy loss before 24 weeks) has passed. We therefore do not know whether use in earlier stages of pregnancy might increase the risk of miscarriage.
Can taking UDCA in pregnancy cause preterm birth, my baby to be small at birth (low birth weight), or stillbirth?
There is no scientific evidence to suggest that women who take UDCA to treat obstetric cholestasis are more likely to have a premature baby (born before 37 weeks of pregnancy), a low birth weight baby (weighing less than 2500g), or a stillbirth than women with obstetric cholestasis who are not taking UDCA. Obstetric cholestasis itself is thought to increase the risk of preterm birth and stillbirth, and some studies suggest that UDCA treatment might help to reduce the risk of these outcomes, although more research is required to confirm this.
Can taking UDCA 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.
There is no known link between taking UDCA in pregnancy and learning or behavioural problems such as ADHD or autism spectrum disorder in the child later on in life. Small studies that include a total of around 120 children who were exposed to UDCA in the womb have not shown any problems with learning or behaviour, but much more research into this subject is required before this can be confirmed.
Will my baby need extra monitoring during pregnancy?
Taking UDCA during pregnancy is not expected to cause any problems that would require extra monitoring of your baby. However, women with obstetric cholestasis are likely to receive extra monitoring, and once they have reached the 37th week of pregnancy may be advised to have their labour started (induced).
Are there any risks to my baby if the father has taken UDCA?
We would not expect any increased risk to your baby if the father took UDCA 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.