EMA probing developmental risks to children of fathers taking epilepsy drug
Karen Keely founder of OACS Ireland, (Organisation Anticonvulsant Syndromes Ireland) an advocacy group for families affected by sodium valproate prescribed during pregnancy. Picture: Moya Nolan
The European Medicines Agency is evaluating a study that could point to an increase in the risk of neurodevelopmental disorders among children whose fathers were treated with an epilepsy drug.
Patients in Ireland have been urged by health authorities and advocates not to stop taking valproate, sold in Ireland as Epilim, without consulting their doctors.
Up to now, the life-changing risks have been more widely understood to relate to infants in the womb whose mothers were prescribed the drug while pregnant. It is used in the treatment of epilepsy, bipolar disorder and other conditions under prescription.
The EMA study, based on registry databases in Norway, Sweden and Denmark, compared children whose fathers were taking valproate in the three months before conception with children whose fathers were using other medication.
The other medications were lamotrigine or levetiracetam, which are also used to treat epilepsy and/or bipolar disorder.
In Ireland, the Health Products Regulatory Authority (HPRA) posted a notice for patients and healthcare workers on its website about these findings.
“The study reported a risk of 5.6% to 6.3% for children born to fathers treated with valproate, compared with 2.5% to 3.6% for children born to fathers treated with lamotrigine or levetiracetam,” the HPRA said.
However, it cautioned patients not to stop taking valproate, which is manufactured by pharmaceutical company Sanofi.
“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,” the HPRA said.
“Sudden discontinuation of any treatment for epilepsy should be avoided as this may lead to seizures.”
This advice also applies to women. The HPRA said evaluation by the EMA was “ongoing”.
Advocacy group OACS Ireland (Organisation Anticonvulsant Syndrome Ireland) supports families whose children suffered life-changing disabilities following exposure to this drug in the womb. Spokeswoman and founder Karen Keely also urged caution.
“While these are concerning findings and may be worrying to men with epilepsy or bipolar disorder who are planning to start a family and/or has a family, it is important to note that further analysis of the data will be undertaken throughout 2023,” she said.
She added: “OACS Ireland will continue to closely monitor developments and we will provide updates on our website and social media channels once further information is available.”
It is now understood babies exposed to valproate in the womb have an 11% risk of birth defects and a 30% to 40% risk of neuro-developmental disabilities which can be permanent, known together as fetal valproate syndrome.
The latest findings follow separate concerns raised by British health authorities last year around the possible risk of impaired fertility in males in addition to the known risks for pregnant women.
Implementation planning for new prescribing rules is ongoing. However, patients there have also been advised they do not need to take action at this point.
