Europe Tightens Valproate Treatment Rules

The European Medicines Agency has recommended precautionary measures for the treatment of male patients with valproate after concerns about an increased risk of neurodevelopmental disorders in children fathered by men treated with the drug. The treatment should be started and supervised by a specialist and the potential risks explained to patients. Regular reviews of the treatment are also recommended, especially when the patient is planning to conceive a child. An observational study in Denmark, Norway, and Sweden showed an increased risk of neurodevelopmental disorders in children born to fathers treated with valproate compared to fathers treated with alternative drugs. The UK’s Medicines and Healthcare products Regulatory Agency has also issued restrictions on the use of valproate.

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