(Date of issue: October 2015. Version: 1)
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?
Sumatriptan (Imigran®) is a medicine used to treat migraine and cluster headaches (severe recurrent headaches on one side of the head, typically around the eye). Sumatriptan is available in tablet form, as a nasal spray, and as an injection.
Is it safe to take sumatriptan in pregnancy?
Not enough information on sumatriptan use in pregnancy is available to determine if there is any risk to an unborn baby. The few studies that have been done do not suggest that the likelihood of birth defects, abnormal growth, or preterm birth is increased but more research is needed. When deciding whether or not to take sumatriptan 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 sumatriptan on a baby in the womb. It is advisable to consider this information before taking sumatriptan if you are pregnant. For some women treatment with sumatriptan in pregnancy may be necessary.
Your doctor is the best person to help you decide what is right for you and your baby.
What if I have already taken sumatriptan 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 sumatriptan 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.
None of the three studies which together included a total of almost 3,000 pregnant women have shown that babies whose mothers took sumatriptan in the first trimester of pregnancy are any more likely to have a birth defect than babies of healthy women who did not take sumatriptan.
Can taking sumatriptan in pregnancy cause miscarriage?
A single study that analysed the data from two smaller studies found that pregnant women taking sumatriptan were about three times more likely to have a miscarriage than (mostly healthy) women not taking sumatriptan. However, miscarriage was just as common in women with untreated migraine. This suggests that any effect might have been due to illness in the mother rather than the sumatriptan. More research is therefore required to determine whether taking sumatriptan in pregnancy increases the chance of miscarriage, or whether the findings of the above studies are due to other factors.
Can taking sumatriptan in pregnancy cause stillbirth?
No studies have investigated whether use of sumatriptan in pregnancy increases the risk of stillbirth.
Can taking sumatriptan in pregnancy cause preterm birth, or my baby to be small at birth (low birth weight)?
Three studies which together included around 700 babies exposed to sumatriptan in the womb investigated possible effects on birth weight and preterm delivery. No evidence of an effect on a baby’s birth weight was identified in any of these studies. Two of the studies also found no evidence that sumatriptan use increases the likelihood of preterm delivery. The third (small) study did, however, show that women taking sumatriptan were more likely than the untreated women with migraine and the healthy untreated women to deliver preterm. More research is therefore required to determine whether sumatriptan use in pregnancy affects the chance of preterm delivery.
Can taking sumatriptan 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.
There is no known link between taking sumatriptan in pregnancy and learning or behavioural problems (such as ADHD or autism spectrum disorder) in the child later on in life. There are, however, no scientific studies that have specifically investigated a link with these problems.
Will my baby need extra monitoring during pregnancy?
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 sumatriptan in pregnancy is not expected to cause problems that would require extra monitoring of your baby.
Are there any risks to my baby if the father has taken sumatriptan?
We would not expect any increased risk to your baby if the father took sumatriptan 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.