Warning for pre-fathers and certain epilepsy medications in women of childbearing potential and during pregnancy
The European Medicines Agency (EMA) has now announced the results of a study to assess the risk of neurodevelopmental disorders and congenital abnormalities (birth defects) in children whose fathers were treated with valproate in the three months before conception.
The study was conducted using data from several databases in Norway, Sweden and Denmark, and compared children whose fathers were treated with valproate in the three months before conception with those whose fathers were treated with lamotrigine or levetiracetam ( medication for bipolar disorder or epilepsy).
May indicate an increased risk of neurodevelopmental disorders, such as autism spectrum disorders, in children whose fathers were treated with valproate . The study reported a risk of 5.6% to 6.3% for children born to valproate- treated fathers, and 2.5% to 3.6% for children born to fathers treated with lamotrigine or levetiracetam .
It was reported that the study continues to be examined and additional data and analyzes are requested from pharmaceutical companies. EMA reported that the result of this evaluation will also be communicated to patients and healthcare professionals.
In addition , a man being treated with valproic acid should not stop taking their medication without talking to their doctor , as epilepsy or bipolar disorder can worsen , which can lead to seizures . warned to avoid abrupt discontinuation of an epilepsy treatment.
Experts mention the following in their warning to patients:
- Keep taking sodium valproate as prescribed by your doctor.
- The child may have mental and/or motor development problems because of Sodium valproate.
- Use effective birth control if you are starting or continuing sodium valproate therapy
- If you have a chance to have children, talk to your doctor about the potential risks of taking Sodium valproate during pregnancy and your options if you want to start a family.