(Date of issue: April 2014. Version: 3)
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?
Botulinum toxin (Botox®, Dysport®, Xeomin®, Bocouture®, Vistabel®, Azzalure®) is commonly known by one of its brand names ‘Botox’. Botulinum toxin is used medically to treat muscle spasms and twitches, squints, excessive sweating, overactive bladder, and migraines. It is also used cosmetically to reduce the appearance of facial lines and wrinkles. Botulinum toxin is injected directly into the site being treated.
Is it safe to use botulinum toxin in pregnancy?
There are no large studies of women who used botulinum toxin during pregnancy, and there is therefore not enough information to accurately assess the safety of botulinum toxin use in pregnant women. It is therefore advisable to only use botulinum toxin during pregnancy if it is absolutely necessary (i.e. if it is needed to treat a medical condition).
When deciding whether or not to use botulinum toxin during pregnancy it is important to weigh up how important its use is to your health against the known or possible risks to you and your baby, some of which will depend on how many weeks pregnant you are.
This leaflet summarises the scientific studies relating to the effects of botulinum toxin on a baby in the womb. It is advisable to consider this information before using botulinum toxin 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 used botulinum toxin during pregnancy?
As with any medicine, you should only continue to use botulinum toxin during pregnancy if it is absolutely necessary. If you are using botulinum toxin for cosmetic purposes you should wait until after your baby has been born before having any further treatment. If you require treatment with botulinum toxin for a medical condition you and your doctor should decide together whether you need to continue with your treatment during pregnancy. In some cases, continuing with treatment for a medical condition may be necessary.
Can using botulinum toxin 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.
Treatment with botulinum toxin during the first trimester has only been described in 18 pregnancies. None of the babies had birth defects, but because such a small number of pregnancies have been studied, much more information needs to be collected before we can say that botulinum toxin doesn’t cause birth defects.
Can using botulinum toxin in pregnancy cause miscarriage, preterm birth, my baby to be small at birth (low birth weight), or stillbirth?
There are no known links between using botulinum toxin during pregnancy and having a miscarriage, a premature baby (born before 37 weeks of pregnancy), a low birth weight baby (weighing less than 2500g), or a stillbirth. There are, however, no scientific studies that have specifically investigated a link with these problems and more research is needed before we can say that botulinum toxin is safe to use in pregnancy.
Can using botulinum toxin 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 using botulinum toxin 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?
Using botulinum toxin during pregnancy is not expected to cause any problems that would require extra monitoring of your baby.
Are there any risks to my baby if the father has used botulinum toxin?
We would not expect any increased risk to your baby if the father used botulinum toxin 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.