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The European Medicines Agency safety committee says there is a potential risk of neurodevelopment disorders in children born to men treated with valproate.
On Jan. 12, 2024, the European Medicines Agency (EMA) announced that its Pharmacovigilance Risk Assessment Committee (PRAC) is recommending that precautionary measures be taken in the use of valproate medicines in male patients. According to PRAC, there is a potential increased risk of neurodevelopmental disorders in children born to men who used valproate medicines during the three months before conception. Male patients receiving valproate treatments should be supervised by a specialist in the management of epilepsy, bipolar disorder, or migraine, PRAC says.
The recommendation comes after the committee reviewed data from a retrospective observational study conducted by companies that market the drugs after a previous review of valproate used during pregnancy using registry databases in Denmark, Norway, and Sweden. The study focused on birth outcomes in children born to men that took valproate, lamotrigine, or levetiracetam around the time of conception. Data was also considered from non-clinical studies, scientific literature, and consultations with patients and clinical experts.
According to the data, approximately five out of 100 children whose fathers were treated with valproate had a neurodevelopmental disorder compared with around three out of 100 children born to fathers treated with lamotrigine or levetiracetam. The risk to children born whose fathers stopped using valproate more than three months before conception was not studied.
“The possible risk in children born to men treated with valproate in the [three] months before conception is lower than the previously confirmed risk in children born to women treated with valproate during pregnancy. It is estimated that up to 30 to 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,” EMA stated in a press release.
“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. The PRAC could therefore not establish whether the increased occurrence of these disorders suggested by the study was due to valproate use. In addition, the study was not large enough to identify which types of neurodevelopmental disorders children could be at increased risk of developing. Nonetheless, the Committee considered precautionary measures were warranted to inform patients and healthcare professionals,” EMA clarified in the release.