Pregabalin

(Date of issue: June 2016. Version: 3.1)

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?

Pregabalin (Lyrica®) is usually taken in combination with other medicines to treat epilepsy. It can also be used to treat anxiety disorders and certain types of nerve pain.

Is it safe to take pregabalin in pregnancy?

There is no yes or no answer to this question. When deciding whether or not to take pregabalin during pregnancy it is important to weigh up how necessary pregabalin 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. Remaining well is particularly important during pregnancy and whilst caring for a baby. It is vital that epilepsy is well-controlled during pregnancy as seizures can harm both mother and unborn child. For some women treatment with pregabalin in pregnancy may be necessary.

It is recommended that all women taking anti-epileptic medicines also take high dose folic acid (5mg/day) whilst trying to conceive and during the first trimester of pregnancy. It is currently not known whether taking high dose rather than the usual recommended dose of folic acid during pregnancy makes any difference to the health of babies born to women who take pregabalin before or during pregnancy. High dose folic acid has to be prescribed by a doctor. For more information please see the folic acid bumps leaflet.

This leaflet summarises the scientific studies relating to the effects of pregabalin on a baby in the womb. It is advisable to consider this information before taking pregabalin 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 taken pregabalin during pregnancy?

If you have taken or are taking 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, if so, to make sure that you are taking the lowest dose that works and only for as long as you need to.

It is very important that you do not suddenly stop taking pregabalin as this could be dangerous to you, and also to your baby if you are already pregnant. Do not make any change to your medication without first talking to your doctor.

Can taking pregabalin 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 unclear whether use of pregabalin in early pregnancy might increase the risk of birth defects in the baby. Two studies have investigated birth defects in the babies in a total of 146 pregnant women taking pregabalin in early pregnancy, with different results. The larger study analysed information on 116 women who took pregabalin in the first trimester of pregnancy. Although birth defects were more common in babies of these women than in babies of pregnant women not taking pregabalin, many of the women taking pregabalin were also taking other medicines, had complex medical illnesses, and were more often smokers. Birth defects were not more common among babies of the 19 women who took only pregabalin in pregnancy.

The second smaller study found that birth defects were no more common in babies of around 30 women who took pregabalin during early pregnancy compared to babies of women not taking pregabalin.

Many more pregnancies, especially where the mother is taking only pregabalin, need to be studied before we can say whether or not taking pregabalin in pregnancy increases the chance of birth defects in the baby.

Pregabalin in combination with other anti-epileptic medicines
Pregabalin is often taken in combination with other medicines to treat epilepsy. Some studies have suggested that women taking combinations of anti-epileptic medicines may be more likely to have a baby with a birth defect than women taking a single anti-epileptic medicine. However, it is now thought that this finding may be due to the fact that many of the women in these studies were taking combinations of anti-epileptics that included sodium valproate (Epilim®), an anti-epileptic medicine that is known to cause birth defects.
 
We do not know whether taking pregabalin in combination with other anti-epileptics in pregnancy increases the chance of birth defects in the baby because no studies have specifically investigated this. More information on women who are taking pregabalin on its own or in combination with other anti-epileptic medicines needs to be collected.

If you are taking more than one medicine to control epilepsy you should discuss any concerns that you may have with your doctor. Do not stop or alter the dose of any medicine you are taking without first speaking to your doctor. Making changes to your medicine yourself may be more harmful to both you and your baby than continuing to take that medicine.

Can taking pregabalin in pregnancy cause miscarriage, stillbirth, preterm birth, or my baby to be small at birth (low birth weight)?

No links between pregabalin use in pregnancy and miscarriage, stillbirth, preterm birth (before 37 weeks of pregnancy) or low birth weight (<2500g) are known about, however no scientific studies have been carried out that have specifically investigated these pregnancy outcomes and more research is required.

Can taking pregabalin in pregnancy cause other health problems in the child?

Withdrawal symptoms at birth (‘neonatal withdrawal’)
Withdrawal symptoms are thought to occur as the newborn baby’s body has to adapt to no longer getting certain types of medicines through the placenta.

Because pregabalin has not been studied specifically, there is no scientific information as to whether taking pregabalin in pregnancy could cause a baby to experience withdrawal symptoms.

However, pregabalin works in a similar way to other medicines that are known to cause neonatal withdrawal. Close monitoring of your baby for a few days after birth may be advised if you have taken pregabalin regularly in the weeks before delivery. Monitoring of your baby may be particularly important if you have taken pregabalin in combination with other anti-epileptic medicines.

Learning and behavioural problems
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 look at whether there is an increased risk of learning and behavioural problems such as autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD) in children who were exposed to pregabalin while in the womb.

Will my baby need extra monitoring?

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 pregabalin in pregnancy would not normally require extra monitoring of your baby. 

If you have taken pregabalin around the time of delivery your baby may require extra monitoring after birth because of the risk of neonatal withdrawal.

Are there any risks to my baby if the father has taken pregabalin?

We would not expect any increased risk to your baby if the father took pregabalin 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.  

General information 

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.

   

www.medicinesinpregnancy.org

Disclaimer: This information is not intended to replace the individual care and advice of your health care provider. New information is continually becoming available. Whilst every effort will be made to ensure that this information is accurate and up to date at the time of publication, we cannot cover every eventuality and the information providers cannot be held responsible for any adverse outcomes following decisions made on the basis of this information. We strongly advise that printouts should NOT be kept for any length of time, or for “future reference” as they can rapidly become out of date.

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