(Date of issue: August 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?
Pizotifen is an antihistamine used to prevent migraine and other types of severe, recurrent headache.
Is it safe to take pizotifen in pregnancy?
There is no yes or no answer to this question. Use of pizotifen is generally not recommended in pregnancy because there are not enough studies of human pregnancies to say that it is safe. However, treatment with pizotifen in pregnancy might be considered necessary for women who experience recurrent headaches that impact significantly on their quality of life or ability to carry out daily activities. When deciding whether or not to take pizotifen during pregnancy it is important to weigh up how necessary pizotifen 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.
This leaflet summarises the available scientific information relating to the effects of pizotifen on a baby in the womb. It is advisable to consider this information if you are taking pizotifen and are pregnant or could become pregnant in the future.
Your doctor is the best person to help you decide what is right for you and your baby.
What if I have already taken pizotifen during pregnancy?
Use of pizotifen is usually only prescribed during pregnancy for women with severe recurrent headaches. Some women who have suffered from migraines prior to pregnancy find that their symptoms improve during pregnancy and may therefore be able to stop their migraine medicines. If you are pregnant and are taking pizotifen you should let your doctor know as soon as possible so that your medication can be reviewed. Your doctor can then assess whether you are on the most suitable medicine(s), are taking the appropriate dose, and whether any of your medicines are no longer necessary.
Can taking pizotifen 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.
It is currently not known whether pizotifen use in pregnancy can cause birth defects in the baby. Only 12 women who took pizotifen in early pregnancy have been studied. None of their babies had major birth defects.
Many more large scientific studies of pregnant women taking pizotifen need to be carried out before we can say whether or not pizotifen increases the risk of birth defects in the baby.
Can taking pizotifen in pregnancy cause miscarriage, stillbirth, preterm birth or my baby to be small at birth (low birth weight)?
It is not known whether use of pizotifen in pregnancy may increase the risk of miscarriage, stillbirth, preterm birth, or low birth weight in the baby because, to date, no studies have addressed these risks. These pregnancy outcomes need to be considered in future research.
Can taking pizotifen in pregnancy cause learning and 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.
No studies have been carried out to investigate whether pizotifen exposure in the womb might affect a child’s learning and behaviour. Nearly all medicines still need to be studied to determine whether exposure in the womb might affect a child’s learning or behaviour.
Will my baby need extra monitoring?
As part of their routine antenatal care most women will be offered a scan at around 20 weeks of pregnancy to look for birth defects and to check the baby’s growth.
Because the effects of pizotifen on a developing pregnancy are unknown your doctor might wish to monitor you more closely and might offer you the option of having more detailed anomaly scans around 12 weeks of pregnancy. It is, however, harder to see birth defects when the baby is still so small, which is why the main scan for birth defects is generally offered at around 20 weeks of pregnancy. It is important to understand that scans are not able to pick up all birth defects and cannot predict whether a baby will have problems with learning and behaviour.
Are there any risks to my baby if the father has taken pizotifen?
No studies have specifically investigated whether pizotifen used by the father can harm the baby through effects on the sperm, however most experts agree that this is very unlikely. More research on the effects of medicine use in men around the time of conception is needed.
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.