The European Medicines Agency's safety committee, PRAC, makes new recommendations for men who plan to have children and who are treated with valproate.
Valproate is an active ingredient found in medications used to treat epilepsy and bipolar disorder, among others. Since before, there have been recommendations for pregnant women to avoid valproate during pregnancy as there is a risk of problems with the baby's growth and malformations, according to the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency.
After reviewing data from registration databases in Sweden, Norway and Denmark, among others, the committee came up with a new recommendation. According to PRAC, there is a potential risk that babies born to men treated with valproate before three months of pregnancy may suffer from neurological and psychiatric problems.
According to the committee, data from records showed that 5 out of every 100 children born to men treated with valproate had neuropsychiatric problems, compared to 3 out of every 100 children born to men treated with other types of medicines to treat similar conditions.
The PRAC Committee therefore now recommends that safety measures be taken and men should be informed of the potential risks of treatment with valproate.
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