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Doctors to inform men taking sodium valproate of risks to unborn children

The European Medicines Agency has recommended new precautionary measures for men taking valproate.

DOCTORS WILL NOW inform men of the potential risks that taking sodium valproate can have on their future children before prescribing it to them. 

The Irish College of General Practitioners (ICGP) has said that doctors will tell patients that their unborn children could be at a higher risk for neurodevelopmental disorders if conceived when they are taking the drug. 

The European Medicines Agency (EMA) has recommended new precautionary measures for men taking valproate, after a study found that there is a potential increased risk of neurodevelopmental disorders in children born to men treated with the drug during the three months before conception.

The study, which used data from Denmark, Norway and Sweden, found that 5 out of 100 children had a neurodevelopmental disorder when born to fathers treated with valproate.

This possible risk is lower than the confirmed risk previously identified in women in pregnancy – up to 30 to 40 out of 100 preschool children whose mothers took valproate during pregnancy may have problems with early childhood development.

The study did not evaluate the risk of neurodevelopmental disorders in children born to fathers who stopped using valproate more than three months before conception.

The EMA said that as the study has limitations it is not possible to confirm that this increased risk is caused by valproate.

Sodium valproate is an oral medication, sold in Ireland under the brand name Epilim, which has been licensed and prescribed worldwide since the 1970s, primarily for the treatment of epilepsy.

It can cause serious birth defects and developmental disorders to an infant if taken during pregnancy and women have been advised against using it unless no other treatment is possible.

The drug has been licensed in Ireland since 1975, and was prescribed here and elsewhere for years after the danger was discovered. Many countries are now investigating its use.

Today, the Health Products Regulatory Authority (HPRA) states that the drug can cause birth defects and problems with the development and learning of the child if their mother takes it during pregnancy.

Children exposed to the drug while in the womb are at a high risk of serious developmental disorders (in up to 30-40% of cases) and congenital malformations (in approximately 10% of cases).

Symptoms of fetal valproate syndrome (FVS) vary, but can include characteristic facial features, spina bifida, congenital heart defects, cleft lip and/or cleft palate, genital abnormalities, skeletal abnormalities and developmental delay.

A number of court cases taken by children over the alleged failure to properly inform their mothers of the risks of taking the drug while pregnant have been settled recently. 


The EMA is now recommending that valproate treatment for men is started and supervised by a specialist in the management of epilepsy, bipolar disorder or migraine.

It is also recommending that doctors inform male patients who are taking valproate about the possible risk and discuss the need to consider effective contraception, for both the patient and their female partner.

Valproate treatment for men should also be reviewed regularly to consider whether it remains the most suitable treatment, particularly when the patient is planning to conceive a child, the EMA said.  

In correspondence issued last week, HSE Chief Clinical Officer Dr Colm Henry informed the ICGP of the new precautionary measures to be taken by GPs in the wake of the EMA’s recommendation. 

The EMA said the potential risk of neurodevelopmental disorders and the precautionary measures will be reflected in updates to the product information and educational material for valproate.

The HPRA, which regulates medicines in Ireland, said the recommendations will now be sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) for adoption.

It said that once a position is adopted, the marketing authorisation holder for Epilim in Ireland will apply to the HPRA to change the terms of their licenses in accordance with the recommendations.

Further communications to healthcare professionals and education materials will then be distributed following HPRA approval. 

“It is anticipated that these regulatory steps will be completed over the next several months,” the HPRA said.

“If you are a man being treated with valproate (Epilim), do not stop taking your medicine without talking to your doctor, as your epilepsy or bipolar disorder could become worse.

“Sudden discontinuation of any treatment for epilepsy should be avoided as this may lead to seizures.”

In a statement, the Organisation for Anticonvulsant Syndromes (OACS) Ireland welcomed the measures. 

“We look forward to working with the HPRA and shall be in close contact with them over the coming weeks and months on the introduction of these measures. We will supply further updates on our website and social media channels as soon as we have them,” the patient group said. 

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