According to the Medicines and Healthcare Products Regulatory Agency (MHRA), there is increased likelihood of neurodevelopmental issues, such as autism, ADHD, tic disorders, or learning difficulties, in children born to men who use the medication valproate.
The warning comes after a January recommendation that, due to reproductive concerns, the medication, which is marketed under the trade names Epilim and Depakote, should only be provided to men and women under the age of 55 in very special cases.
A new study from Scandinavia indicates that five out of 100 babies delivered to men who received valproate treatment had a neurodevelopmental disorder, according to the MHRA.
The medicines authorities issued precautionary advise despite the fact that the study does not establish that the drug is the source of the higher risk.
It states that during the course of therapy and for three months following treatment cessation, male patients and their partners should utilize an effective form of contraception.
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