All antiepileptic medicines carry a risk to an unborn baby if the mother is taking them due to a medical reason. Some antiepileptic medicines carry a higher risk than others.
Please consult your healthcare professional prior to stopping your medicine.
Not all babies exposed to antiepileptic medicine during pregnancy will be affected.
Information and Data on the use of medicines in pregnancy is generally lacking due to insufficient funding and research. This is something we here at INFACT are continuously campaigning for.
Through the longevity of our work and campaigning and having liased with Medicines Healthcare Regulatory Agency, Commission of Human Medicines over the years what we do know is that drug manufacturers, when launching a medication do have an obligation to carry out clinical trials on mammals, mice, rats, rabbits, this gives a high indication on the affects the medication will have on a human.
The drug manufacturer (marketing authorisation holder) then disclose the findings of the Clinical trials to Medicine Regulators such as MHRA/FDA. It is then the decision of the regulators to disclose what information is inserted onto the Patient Information Leaflet that comes in the box of the medication.
On the PIL there is lots of information and typically many people do not read these leaflets.
For clear accessabilty of information below is a list of medications with the relevant information with regards to pregnancy and breastfeeding. On the title of the medication, click on the link that will take you to the Original Patient Information Leaflet
“Your doctor will discuss with you the potential risk of taking Tegretol during pregnancy since it may cause harm or abnormalities in the unborn child. You must discuss your epilepsy treatment with your doctor well before you become pregnant.
If you do get pregnant while you are taking Tegretol Tablets you must tell the doctor straightaway. It is important that your epilepsy remains well controlled, but, as with other anti-epilepsy treatments, there is a risk of harm to the foetus.
Make sure you are very clear about the risks and the benefits of taking Tegretol Tablets.
Breastfeeding Mothers taking Tegretol Tablets can breastfeed their babies, but you must tell the doctor as soon as possible if you think that the baby is suffering side effects such as excessive sleepiness, skin reaction or yellow skin and eyes, dark urine or pale stools.
Fertility You should use an effective method of contraception throughout your treatment with Tegretol and for a period of 28 days, after discontinuation of treatment. Irregularity of the menstrual period may occur in women taking hormonal contraceptives (birth control medicines) and Tegretol.
The hormonal contraceptive may become less effective and you should consider using a different or additional non-hormonal contraceptive method. Ask your doctor about effective contraception.”
This leaflet was revised in 11/2020.
Carbimazole Tablets can cause harm to an unborn baby.
If you could get pregnant, use reliable contraception from the time you start treatment and during treatment. However, to reduce the possibility of any effects on your baby: • Your doctor should prescribe the lowest dose possible. • Your treatment may be discontinued three to four weeks before you are due to give birth. Your treatment with Carbimazole Tablets may need to be continued during pregnancy if the potential benefit outweighs the potential risk to you and your unborn baby. Breast-feeding You should not breast-feed if you are using Carbimazole Tablets. This is because small amounts may pass into the mother’s milk. Ask your doctor or pharmacist for advice before taking any medicine
This leaflet was last revised in January 2020
Do not take Clobazam Tablets if you are:
• a woman of childbearing potential and are not using contraception
• in the first three months of pregnancy
• breast-feeding.
This is because it may pass into the mother’s milk.
Talk to your doctor before taking this medicine if you are pregnant, plan to get pregnant, or think
you may be pregnant. This is because Clobazam 10mg Tablets are not recommended for use in
pregnant women.
However, your doctor may give you this medicine during late pregnancy or during labour.
• if this happens, there is a risk of having a baby with a low body temperature, floppiness,
breathing or feeding problems
• if this medicine is taken regularly in late pregnancy, your baby may get withdrawal symptoms.
In this case the newborn should be closely monitored during the postnatal period.
This leaflet was last revised in September 2020
Clonazepam
You must not take
Clonazepam if you are pregnant, might become pregnant or are breast-feeding,
unless your doctor tells you to. Clonazepam is known to have harmful
effects on the unborn child.
This leaflet was last revised in 06/2019
Do not take Diazepam tablets if you are pregnant,
might become pregnant or breast-feeding.
If you and your doctor decide that you should take this medicine towards the end of your pregnancy (or during labour)
this may harm your baby. The baby may have a low temperature, be listless, have breathing problems or difficulty in feeding. Also, if you take this medicine regularly during your pregnancy your baby may get withdrawal symptoms. If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine
Date of Revision: August 2020
If you are of childbearing age, your doctor will advise you regarding the need for planning and monitoring any pregnancy before starting treatment with Ethosuximide
Aristo. Do not stop taking Ethosuximide Aristo without first consulting your doctor, as epileptic seizures (fits) might recur, which could harm you and/or your unborn
child.
No specific malformations of babies are known which were caused by treatment with ethosuximide. However, patients treated with anti-epileptic medicines generally
have a higher risk for malformations than other women.
The most commonly reported malformations are cleft lip, cardiovascular malformation and neural tube defects (spina bifida). This risk is even higher in patients treated
with more than one anti-epileptic, and therefore combination treatment should be avoided during pregnancy.
Prenatal diagnostic measures such as high level ultrasound and the determination of α-fetoprotein are recommended for the early detection of damage to the
foetus. The lowest effective dose that ensures seizure control must not be exceeded, particularly during the 20th and 40th day of pregnancy. Your ethosuximide serum
concentration must be checked regularly. You should take extra folic acid if you are planning to have a baby or if you are pregnant.
To prevent vitamin K1 deficiency in your baby, and bleeding caused by this deficiency, you should also be given vitamin K1 during the last month of your pregnancy.
This leaflet was last revised in 02/2021
Pregnancy – Gabapentin capsules should not be taken during pregnancy, unless you are told otherwise by your doctor.
Effective contraception must be used by women of child-bearing potential. There have been no studies specifically looking at the use of gabapentin in pregnant women, but other medications used to treat seizures have reported an increased risk of harm to the developing baby, particularly when more than one seizure medication is taken at the same time. Therefore, whenever possible, you should try to take only one seizure medication during pregnancy and only under the advice of your doctor.
Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking Gabapentin capsules. Do not suddenly discontinue taking this medicine as this may lead to a breakthrough seizure, which could have serious consequences for you and your baby.
Breast feeding – Gabapentin, the active substance of Gabapentin capsules, is passed on through human milk. Because the effect on the baby is unknown, it is not recommended to breast-feed while using Gabapentin capsules. Ask your doctor or pharmacist for advice before taking any medicine. Fertility – There is no effect on fertility in animal studies.
This leaflet was last revised in 04/2019
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It is not recommended to take Vimpat if you are pregnant or breast-feeding, as the effects of Vimpat on pregnancy and the unborn baby or the new-born child are not known. Also, it is not known whether Vimpat passes into breast milk.
Seek advice immediately from your doctor if you get pregnant or are
planning to become pregnant. They will help you decide if you should take Vimpat or not.
Do not stop treatment without talking to your doctor first as this could increase your fits (seizures). A worsening of your disease can also harm your baby
This leaflet was last revised in January 2021
Contact your doctor if you are pregnant or might become pregnant or planning to become pregnant.
It’s important that you do this because there may be an increased risk of birth defects in babies whose mothers took Lamotrigine during pregnancy. These defects include cleft lip or cleft palate.
Your doctor may advise you to take extra folic acid if you’re planning to become pregnant and while you’re pregnant. Pregnancy may also alter the effectiveness of Lamotrigine, so your doctor may take samples of your blood to check the level of Lamotrigine, and may adjust your dose.
If you are pregnant, think you may be pregnant or are planning to have a baby ask your doctor or pharmacist for advice before taking this medicine. You should not stop treatment without discussing this with your doctor. This is particularly important if you have epilepsy. Talk to your doctor if you’re breast feeding or planning to breast feed. If you are breast-feeding or planning to breast-feed ask your doctor or pharmacist for advice before taking this medicine. The active ingredient of Lamotrigine passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breast-feeding while you’re taking lamotrigine, and will check your baby from time to time, whether drowsiness, rash or poor weight gain occurs, if you decide to breast-feed. Inform your doctor if you observe any of these symptoms in your baby. Lamotrigine passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breast feeding while you’re taking Lamotrigine, and will check your baby from time to time if you decide to breast feed. Ask your doctor or pharmacist for advice before taking this medicine.
This leaflet was last revised in 01/2021.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Levetiracetam can be used during pregnancy, only if after careful assessment it is considered necessary by your doctor. You should not stop your treatment without discussing this with your doctor.A risk of birth defects for your unborn child cannot be completely excluded. Breast-feeding is not recommended during treatment.
This leaflet was last revised in 02/2020
Do not take this medicine if you are pregnant, or might become pregnant, without
consulting your doctor. Benzodiazepines, including lorazepam, may cause damage to
the foetus if taken during early pregnancy.
If you take this medicine during late pregnancy or during labour, your baby, when born,
may be less active than other babies, have a low body temperature, be floppy, or have
breathing or feeding difficulties for a while. Your baby’s response to the cold might be
temporarily impaired. If this medicine is taken regularly in late pregnancy, your baby
may develop withdrawal symptoms after birth.
Do not take this medicine if you are breast-feeding, since the drug may pass into
breast milk, and cause the baby to be less active and unable to suckle
This leaflet was last revised in July 2020
Oxcarbazepine affects the way hormonal contraceptives work and there is a risk of getting pregnant. You should use other contraceptives if you are of a child-bearing age. It is important to control epileptic seizures during pregnancy. However, there may be a risk to your baby if you take antiepileptic medicines during pregnancy. Your doctor will tell you the benefits and potential risks involved and help you to decide whether you should take Oxcarbazepine Mylan.
Do not stop your treatment with Oxcarbazepine Mylan during pregnancy without first checking with your doctor.
Breast-feeding
You should not breast-feed while taking Oxcarbazepine Mylan. The active substance in
Oxcarbazepine Mylan passes into breast milk. This could cause side effects for breast-fed babies.
This leaflet was last revised in April 2021
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking Phenobarbital tablets. Your doctor should discuss the possible effects of Phenobarbital tablets on the unborn child and the risks and benefits of treatment should be considered carefully. Check with your doctor before taking folic acid supplements as they interact with Phenobarbital tablets, your doctor may need to adjust your
dose.
If you are taking Phenobarbital tablets, do not breastfeed, as the medicine
will pass into the breast milk and may harm the baby.
This leaflet was last revised in March 2019
If you are pregnant consult your doctor promptly. You should not stop taking your medicine until you have discussed this with your doctor. Stopping your medication without consulting your doctor could cause seizures which could be dangerous to you and the pregnancy. Your doctor may decide to change your treatment. Closer monitoring of your unborn child could also be considered.
Phenytoin Capsules may cause birth defects. If you take Phenytoin Capsules during pregnancy your baby has a higher risk of having a birth defect. Birth defects which have been reported include facial, skull, nail, finger and heart abnormalities.
If you are of childbearing age and plan to become pregnant, consult your doctor for a
preconceptional visit.
You should discuss your treatment options with your doctor.
If you take Phenytoin Capsules during pregnancy, your baby is also at risk of bleeding problems right after birth. Your doctor may give you and your baby a medicine to prevent this. Moreover, your child should be closely monitored.
Contraception in women
If you are of childbearing age, you should discuss your treatment options and effective methods of birth control with your doctor. Phenytoin Capsules may result in a failure of hormonal contraceptives, hence you should be counselled regarding the use of other effective contraceptive
methods.
This leaflet was last revised in January 2020.
This medicine should not be taken during pregnancy or when breast-feeding, unless you are told otherwise by your doctor. Effective contraception must be used by women of child-bearing potential. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
This leaflet was approved in 01/2021
The use of Mysoline in pregnancy is associated with an increased risk of abnormalities in babies. Primidone is likely to cause malformations in the unborn child (especially cleft lip and palate, cardiovascular malformations and abnormality of the penis in male babies) when administered during pregnancy. Therefore, you must tell your doctor if you are pregnant, or trying to become pregnant
Your doctor will talk to you about potential benefit of continuation of the treatment or whether another
medication maybe more suitable for you. If you continue treatment,
During pregnancy: your doctor will adjust your dose to get the minimum effective dose for you. Before delivery: you will need to take vitamin K to prevent the bleeding this medicine may cause during the first 24 hours of your baby’s life.
After childbirth: an injection of vitamin K may also be prescribed to your baby, at birth, to avoid any bleeding.
Do not interrupt your treatment suddenly; this could lead to the recurrence of seizures, which would have serious consequences for you and your child.
It is recommended that you use effective contraception during treatment. Primidone can make the contraceptive pill ineffective and you should use another effective method of contraception – ask your doctor for advice regarding effective contraception.
Effects in the new born
The new born child may develop withdrawal symptoms if the mother has taken Mysoline in the late stages of pregnancy. Blood clotting problems have occurred occasionally in children born to women who were previously taking anticonvulsant drugs.
Breast-feeding is not recommended as Primidone is found in breat milk and can make the baby sleepy.
Contact your doctor if you are breastfeeding or want to breastfeed.
This leaflet was last approved on September 2019
Valproate can seriously harm an unborn child when taken during pregnancy. If you are a female able to have a baby you must use an effective method of birth control (contraception) without interruptions during your entire treatment with Sodium Valproate
Tablets. Your doctor will discuss this with you but you must also follow
the advice in section 2 of this leaflet. Schedule an urgent appointment
with your doctor if you want to become pregnant or if you think you
are pregnant.
Do not stop taking Sodium Valproate Tablets unless your doctor tells you to
as your condition may become worse. If you are a parent or caregiver of a
female child treated with Sodium Valproate Tablets you must also read
section 2 of this leaflet carefully and contact your child’s doctor once they
experience their first period.
The risks of valproate when taken during
pregnancy
• Talk to your doctor immediately if you are
planning to have a baby or are pregnant.
• Valproate carries a risk if taken during
pregnancy. The higher the dose, the higher the
risks but all doses carry a risk.
• It can cause serious birth defects and can
affect the way in which the child develops as it
grows. Birth defects which have been reported
include spina bifida (where the bones of the
spine are not properly developed); facial and
skull malformations; heart, kidney, urinary
tract and sexual organ malformations; limb
defects. Hearing problems or deafness have
been reported in children exposed
to valproate during pregnancy.
• If you take valproate during pregnancy you
have a higher risk than other women of having
a child with birth defects that require medical
treatment. Because valproate has been used
for many years we know that in women who
take valproate around 10 babies in every 100
will have birth defects. This compares to 2 to 3
babies in every 100 born to women who don’t
have epilepsy.
• It is estimated that up to 30-40% of preschool
children whose mothers took valproate during
pregnancy may have problems with early
childhood development. Children affected can
be slow to walk and talk, intellectually less able
than other children, and have difficulty with
language and memory.
• Autistic spectrum disorders are more often
diagnosed in children exposed to valproate
and there is some evidence children may be
more likely to develop symptoms of Attention
Deficit Hyperactivity Disorder (ADHD).
• Before prescribing this medicine to you, your
doctor will have explained what might happen
to your baby if you become pregnant whilst
taking valproate. If you decide later you want
to have a baby you must not stop taking your
medicine or your method of contraception
until you have discussed this with your doctor.
• If you are a parent or a caregiver of a
female child treated with valproate, you
should contact the doctor once your child
experiences their first period (menarche)
I AM PREGNANT AND I AM USING SODIUM
VALPROATE TABLETS
Do not stop taking Sodium Valproate Tablets, unless your doctor tells you to as your condition may become worse. Schedule an urgent appointment with your doctor if you are
pregnant or think you might be pregnant. Your doctor will advise you further.
Babies born to mothers who have been on valproate are at serious risk of birth defects
and problems with development which can be seriously debilitating.
You will be referred to a specialist experienced in the management of epilepsy, so that alternative treatment options can be evaluated.
In the exceptional circumstances when Sodium Valproate Tablets is the only available treatment option during pregnancy, you will be monitored very closely both for the management of your underlying condition and to check how your
unborn child is developing. You and your partner could receive counselling and support regarding the valproate exposed pregnancy.
Ask your doctor about taking folic acid. Folic acid
can lower the general risk of spina bifida and
early miscarriage that exists with all pregnancies.
However, it is unlikely that it will reduce the risk
of birth defects associated with valproate use.
Key messages:
• Schedule an urgent appointment with your
doctor if you are pregnant or think you might
be pregnant.
• Do not stop taking valproate unless your
doctor tells you to.
• Make sure you are referred to a specialist
experienced in the treatments of epilepsy to
evaluate the need for alternative treatment
options.
• You must get thorough counselling on the
risks of Sodium Valproate Tablets during
pregnancy, including teratogenicity and
developmental effects in children.
• Make sure you are referred to specialist
for prenatal monitoring in order to detect
possible occurrences of malformations.
Make sure you read the patient guide that you
will receive from your doctor. Your doctor will
discuss the Annual Risk Acknowledgement
Form and will ask you to sign it and keep it.
You will also receive a Patient Card from your
pharmacist to remind you of valproate risks in
pregnancy.
Newborn babies of mothers who took
valproate during pregnancy may have:
• Blood clotting problems (such as blood not
clotting very well). This may appear as bruising
or bleeding which takes a long time to stop.
• Hypoglycaemia (low blood sugar).
• Hypothyroidism (underactive thyroid gland,
which can cause tiredness or weight gain).
• Withdrawal syndrome (including agitation,
irritability, hyperexcitability, jitteriness,
hyperkinesia, muscle problems, tremor,
convulsions and feeding problems). In
particular, this may occur in newborns whose
mothers have taken valproate during the last
trimester of their pregnancy.
Topiramate tablets can harm an unborn baby. You must not use topiramate tablets if you are pregnant. You must not use topiramate tablets for migraine prevention if you are a woman of childbearing potential unless you are using effective contraception.
Talk to your doctor about the best kind of contraception and whether topiramate tablets is suitable for you.
Before the start of treatment with topiramate tablets a pregnancy test should be performed. Treatment of epilepsy: If you are a woman of childbearing potential you should talk to your doctor about other possible treatments instead of topiramate tablets. If the decision is made to use topiramate tablets, you should use effective contraception. Talk to your doctor about the best kind of contraception to use while you are taking topiramate tablets. Before the start of treatment with topiramate tablets a pregnancy test should be performed. Talk to your doctor if you wish to become pregnant. As with other anti-epileptic medicines, there is a risk of harm to the unborn child if Topiramate is used during pregnancy. Make sure you are very velar about the risks and the benefits of using Topiramate for epilepsy during pregnancy. – If you take topiramate tablets during pregnancy, your baby has a higher risk for birth defects, particularly, cleft lip (split in the top lip) and cleft palate (split in the roof of the mouth). Newborn boys may also have a malformation of the penis (hypospadia). These defects can develop early in pregnancy, even before you know you are pregnant. – If you take topiramate tablets during pregnancy, your baby may be smaller than expected at birth. Talk to your doctor if you have questions about this risk during pregnancy. – There may be other medicines to treat your condition that have a lower risk of birth defects. – Tell your doctor straight away if you become pregnant while taking topiramate tablets. You and your doctor should decide if you will continue to take topiramate tablets while you are pregnant.
Breast-feeding The active substance in topiramate tablets (topiramate) passes into breast milk. Effects have been seen in breastfed babies of treated mothers, including diarrhea, feeling sleepy, feeling irritable, and poor weight gain. Therefore, your doctor will discuss with you whether you abstain from breastfeeding or whether to abstain from treatment with topiramate tablets. Your doctor will take into account the importance of the medicine to the mother and the risk for the baby. Mothers who breastfeed while taking topiramate must tell the doctor as soon as possible if the baby experiences anything unusual.
This leaflet was last revised in 08/2020.
INFACT 