EMA issues warning for males with epilepsy or bipolar disorder being treated with group of medicines

The European Medicines Agency (EMA) has issued a warning for male patients with epilepsy or bipolar disorder being treated with the valproate group of medicines. It follows the identification of a potential increased risk of neurodevelopmental disorders in children born to men treated with valproate during the three months before conception.

At its January meeting, the EMA’s risk committee reviewed data from a Scandinavian observational study carried out as part of mandatory post marketing research by manufacturers of the drugs.

The neurodevelopmental disorders include problems with development that begin in early childhood, such as autism spectrum disorders, intellectual disability, communication disorders, attention deficit/hyperactivity disorders and movement disorders.

The data showed that about five out of 100 children had a neurodevelopmental disorder when born to fathers treated with valproate compared with about three out of 100 when born to fathers treated with alternative drugs.

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As part of its warning, the EMA recommends that valproate treatment in male patients is started and supervised by a specialist in the management of epilepsy or bipolar disorder. In addition, doctors have been asked to inform male patients who are taking valproate about the potential risk and discuss the need to consider effective contraception.

“Valproate treatment of male patients should be reviewed regularly to consider whether it remains the most suitable treatment, particularly when the patient is planning to conceive a child,” it says.

There is a previously confirmed risk of neurological harm in children born to women treated with valproate during pregnancy. It is estimated that up to 30-40 out of 100 preschool children whose mothers took valproate during pregnancy may have problems with early childhood development, such as being slow to walk and talk, being intellectually less able than other children, and having difficulty with language and memory.

The Health Service Executive (HSE) estimates that up to 1,250 families have been impacted by exposure to valproate in pregnancy since the 1970s. According to Epilepsy Ireland, more than 45,000 people here have epilepsy, making it is one of the most common neurological conditions in the country.

The EMA noted the study data on male patients had limitations, including differences between the groups in the conditions for which the medicines were used and in follow-up times. In addition, the study was not large enough to identify which types of neurodevelopmental disorders children could be at increased risk of developing. Nonetheless, its risk committee considered precautionary measures were warranted to inform patients and healthcare professionals.

The EMA asks patients already taking valproate not to stop treatment prior to consulting a doctor. It also advises men not to donate sperm when taking valproate and for three months after stopping the drug.

The active ingredient in valproate medicines sold in Ireland is sodium valproate. It is marketed under trade names such as Epilim, Epilim Chrono and Epilim Chronosphere.