Date: November 2018, Version 1.0

What is it?

Xonvea® is a medicine that is used to treat nausea and vomiting in pregnancy. It is taken as a tablet and contains an antihistamine called doxylamine, as well as vitamin B6.

Is it safe to take Xonvea® in pregnancy?

Xonvea® is licensed for use in pregnant women. Studies have shown that Xonvea® does not cause birth defects in the baby; however other potential effects of this medicine have not been well studied. This leaflet summarises all of the available information on pregnant women who have taken medicines with the same active ingredients as Xonvea®.

Can taking Xonvea® cause miscarriage?

There are no well-designed studies to investigate the risk of miscarriage following use of Xonvea® in early pregnancy.

Can taking Xonvea® 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.

Studies of thousands of pregnant women taking medicines with the same active ingredients as Xonvea® provide no proof of a link with birth defects in the baby.

Can taking Xonvea® in pregnancy cause stillbirth?

No studies have investigated the chance of stillbirth following use of Xonvea® in pregnancy.

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

A small study raised no concerns that exposure in early pregnancy to medicines with the same active ingredients as Xonvea® affects the chance of preterm birth or the baby’s birth weight. Larger studies are required to confirm these findings.

Can taking Xonvea® 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.

Two small studies assessed the learning and behaviour of children aged up to seven years who had been exposed  in the womb to medication with the same ingredients as Xonvea®. Although no problems were noted, much larger studies that investigate many more aspects of learning and behaviour are required to confirm these findings.

Will I or my baby need extra monitoring during pregnancy?

Most women will be offered a scan at 20 weeks of pregnancy to look for birth defects as part of their routine antenatal care. Use of Xonvea® in early pregnancy is not expected to cause any problems that would require additional scanning.

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.

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.