(Date of issue: March 2014. 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?
Methylphenidate (Ritalin®, Concerta XL®, Equasym XL®, Medikinet XL®) is prescribed to treat attention deficit hyperactivity disorder (ADHD), and occasionally for narcolepsy (a rare sleep disorder where affected individuals suddenly fall asleep at inappropriate times throughout the day).
Is it safe to take methylphenidate in pregnancy?
There is no yes or no answer to this question. When deciding whether or not to take methylphenidate 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 methylphenidate on a baby in the womb. It is advisable to consider this information before taking methylphenidate if you are pregnant. For some women, treatment with methylphenidate 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 methylphenidate during pregnancy?
If you 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 to make sure that you are taking the lowest dose that works.
It is very important that you do not suddenly stop taking methylphenidate. Do not make any changes to your medication without first talking to your doctor.
Can taking methylphenidate 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.
There is no scientific evidence from four small studies to suggest that that taking methylphenidate during the first three months of pregnancy causes birth defects. However, because only limited numbers of women have been studied, further research is required before an increased risk of birth defects with methylphenidate use in pregnancy is ruled out.
Can taking methylphenidate in pregnancy cause miscarriage or stillbirth?
No links between methylphenidate use in pregnancy and having a miscarriage or a stillbirth are known about, however no scientific studies have been carried out that have specifically investigated these pregnancy outcomes.
Can taking methylphenidate in pregnancy cause preterm birth, or my baby to be small at birth (low birth weight)?
Two studies show no difference in the stage of pregnancy at delivery between babies who were exposed to methylphenidate while in the womb and babies who were not. One of these studies also showed no obvious difference between the birth weights of the babies in these two groups. These studies did not specifically investigate whether preterm birth (delivery before 37 weeks of pregnancy), or of the baby having a low birth weight (less than 2500g), was more common with methylphenidate use in pregnancy.
Has taking methylphenidate in pregnancy been linked to 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 methylphenidate has not been studied separately, there is no scientific information as to whether taking methylphenidate in pregnancy could cause a baby to experience withdrawal symptoms.
However, because methylphenidate works in a similar way similar 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 methylphenidate in the weeks before delivery.
Developmental delay, behavioural and psychological 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 methylphenidate while in the womb.
Will my baby need extra monitoring during pregnancy?
If you have taken methylphenidate around the time of delivery, because of the risk of withdrawal symptoms in the baby, he/she may require extra monitoring after birth.
Are there any risks to my baby if the father has taken methylphenidate?
We would not expect any increased risk to your baby if the father took methylphenidate 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.