Safety measures related to the prescribing of valproate medicines in new male patients under the age of 55 years and guidance on the use of contraceptives are sufficient to minimize safety risks in children born to men taking the drug, according to the UK Medicines and Healthcare products Regulatory Agency.
UK MHRA Will Not Implement Stricter Review For Existing Male Valproate Patients
The UK drug regulator says that men under the age of 55 years who are already taking valproate will not need to be reviewed by two specialists, as this measure is “unlikely to minimize risks” of neurodevelopmental disorders in children conceived by them any further.
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