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A study published in Epilepsia suggested that children whose mothers took antiepileptic drugs (AEDs) while pregnant are at increased risk of early development issues, such as motor development, language skills, social skills, and autistic traits compared to children whose mothers did not take anti-seizure medications.
Prof Jørgen Scheel-Krüger, Center for Functionally Integrative Neuroscience, Aarhus University, where they are developing an animal model of the effects of antiepileptic drugs, said:
“This paper is an extensive study with appropriate control groups. The finding is surprising, as up until now it has only been thought that one compound of these drugs (Valproate) was associated with increased risk of autism. Now, we know that such an association occurs also for other compounds, including the commonly used Lamotrigine. It is extremely important to take account of these findings in practice.”
Delphine van der Pauw, Research and Information Executive at Epilepsy Research UK, said:
“This is an interesting study, which supports the findings of other research groups. However, the results aren’t conclusive, because there are a number of factors that can contribute to cognitive delay in children that haven’t been accounted for (e.g. severe morning sickness and gestational hypertension (seen more commonly in epilepsy) and the mother’s own IQ and developmental history). Also the design of the study, while appropriate, included little medical validation of epilepsy diagnoses, or of mothers’ scoring patterns, and this increases the risk of inaccuracy and bias.
“Women with epilepsy need to carefully plan (with their doctors) the best way to manage their condition during pregnancy, and in order to do this effectively they need as much information as possible about the potential impact of individual drugs.
“On its own, this study adds little additional insight, because it includes no details about drug dosing (i.e. the actual exposure of the child), and the numbers of people in each drug category were too low for results to be conclusive. However, the findings obtained here will hopefully be used to form the basis of a much larger study.”
Other info about epilepsy
Dr June Raine, Director of Vigilance and Risk Management of Medicines, MHRA, said:
“These findings are not new. No medicine is completely free from side effects, and the use of any medicine in pregnancy requires a careful clinical evaluation of the benefits and risks to the woman and to her unborn child.
“When considering these, it’s important to remember that untreated epilepsy carries serious risk for the mother and to her unborn child.
“We continually monitor the safety of medicines – our safety surveillance systems are among the best in the world – but we are not complacent and we are constantly working to improve them.
“The safety of medicines in pregnancy is a key priority for us. We have regularly updated the information for patients and healthcare professionals about the safety of these medicines in pregnancy.”
How the MHRA monitors problems with medicines:
“We continually monitor medicines in clinical use for any possible adverse effects in pregnancy, using a range of well-established data sources. These include:
“The UK’s Yellow Card scheme is a proven way of identifying new or changing risks in real world use. For example, Yellow Cards would pick up signal of a rare birth defect associated with a medicine, such as the limb abnormality with thalidomide, with as few as 5 or 6 cases.
“We update the information for health professionals and patients as soon as a signal has been thoroughly evaluated, and seek input from specialist experts in clinical practice. We send a regular bulletin Drug Safety Update to healthcare professionals, and the authorised product information is available on the MHRA website and is kept up to date.
“We are not complacent and are continually working to improve our safety surveillance methods. We use a range of sources of healthcare data to study safety signals, and the Clinical Practice Research Datalink here at MHRA has the capability to link a mother’s record with her baby’s. We are working with Public Health England to establish linkage of local pregnancy registries, and within the EU network of centres of pharmacovigilance and pharmacoepidemiology to set up a research network for drugs in pregnancy.”
David Branford, mental health spokesperson for the Royal Pharmaceutical Society, said:
“This is a really useful study which builds on the information we already have about the effects of anti-epileptic drugs taken during pregnancy and shows how they can affect children’s development.
“However, this paper doesn’t change the basic advice to women with epilepsy. Women should talk to their specialist, if possible prior to becoming pregnant, to discuss their own situation. Whilst each case is different, the general consensus is that women should remain on an anti-epileptic drug during pregnancy but it is worth looking at if you can switch drugs or reduce the dose.
“Women should have additional tests throughout their pregnancy to detect any problems and given careful counseling. It’s also recommended they take a higher dose of folic acid during this time.”
Prof Jean Golding, Emeritus Professor of Paediatric & Perinatal Epidemiology, Centre for Child & Adolescent Health, University of Bristol, said:
“This study concerns information gained in pregnancy by the world-famous MoBA study in Norway. It has advantages over many other studies in having a large population of women, medication information collected before the baby was born, and good follow-up. It is not new that anticonvulsant drugs are related to congenital malformations, and there have been some reports previously that the children born to women taking these drugs tend to be delayed in their motor development. The association found with autistic traits is potentially important but requires confirmation in other prospective studies.”
Dr Ian Jones, Reader in Perinatal Psychiatry, MRC Centre for Neuropsychiatric Genetics and Genomics, Cardiff University, said:
“This study adds to the evidence suggesting there are important issues to consider for women who take anti-epileptic medication in pregnancy. We know that a number of these medications have been shown to increase risk of babies being born with malformations and, in the case of sodium Valproate, have been linked to later problems in the cognitive development of the child. In addition to their use in women with Epilepsy these drugs are also used in women with psychiatric illness, particularly bipolar disorder.
“As with all studies in this area – it is difficult to know how much of the increased risk is due to the medication and how much is due to other factors such as the severity of the disorder itself.
“The decision to take medication in pregnancy is always difficult. Women and their doctors need to weigh up the risks and benefits of all options taking into account her individual circumstances. In making these difficult decisions it’s important to recognise that the illness itself may have negative consequences for the women, her baby and her family, and these must be weighed against what we know about the risks of medication. What is clear is that women should not stop their medication suddenly without discussing the options with their doctor.
“Lastly, this should not be an issue just when a women becomes pregnant. We must consider the possibility of current or future pregnancy when prescribing to all women in their childbearing years. Doctors should discuss the risks in pregnancy and decisions around contraception with women when these medications are first prescribed.”
‘Exposure to antiepileptic drugs in utero and child development — A prospective population-based study’ by Veiby et al. published in Epilepsia on Thursday 18th July.