Ursodeoxycholic acid

Date: May 2020, Version 3

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 ‘Treatment of 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.

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.