EMA warns of risk to babies from fathers taking epilepsy drug
Disorders Of Men European Valproate, Increased To Drug Children Have Born Epilepsy Neurodevelopmental May The Containing Agency Say Medicines An That Medicine Prescribed Risk
The European Medicines Agency has said men who use prescribed medicine containing valproate should discuss contraception with their doctors as it could pose a risk to babies.
The EMA said the drug could pose “a potential increased risk of neurodevelopmental disorders in children born to men treated with valproate during the three months before conception”.
Commonly sold in Ireland as Epilim, valproate is used to treat epilepsy, bipolar disorder and migraine.
The EMA is now recommending valproate treatment for men be started and supervised by a specialist in epilepsy, bipolar disorder or migraine.
“Doctors should 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,” they advised.
The decision is based on various data including a study in Denmark, Norway and Sweden.
This looked at outcomes for men taking valproate compared to men taking other medicines used to treat conditions similar to those valproate treats.
“… around 5 out of 100 children had a neurodevelopmental disorder when born to fathers treated with valproate compared with around 3 out of 100 when born to fathers treated with lamotrigine or levetiracetam,” the EMA said.
“The study did not investigate the risk in children born to men who stopped using valproate more than three months before conception.”
Doctors in the EU were previously advised not to prescribe valproate for pregnant women, women who can become pregnant or girls unless other treatments are ineffective or not tolerated.
The HSE advises taking Epilim when pregnant “can seriously harm your unborn child”.
Risks include, it says, one in 10 babies having bodily malformation at birth, three or four in 10 having serious developmental disorders.
The risk of childhood autism is five times more likely than in the general population and children are more likely to develop ADHD.
The EMA lists 20 other brand-names, in an alert on their website.
Karen Keely, founder of advocacy group OACS Ireland (Organisation Anticonvulsant Syndromes Ireland) welcomed the move.
“We know that this latest information may be worrying for men with epilepsy and other conditions who are planning to start a family and have already had a family while on Epilim, sodium valproate,” she said.
The EMA has not published the full study, but she understands this is expected in the coming months.
In Ireland the Health Products Regulatory Authority monitors medication.
It said of the EMA recommendation: “It is anticipated that these regulatory steps will be completed over the next several months.
“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.”
- Contact OACS Ireland: https://oacsireland.com/