The European Medicines Agency (EMA) has issued various precautionary measures governing treatment of male patients with valproate after concerns of a heightened risk for neurodevelopmental disorders in children fathered by men treated with the drug in the three months before conception.
Valproates are used to treat epilepsy and bipolar disorder; some European Union (EU) member states also sanction its use for treating migraine, writes Medscape.
In 2022, MedicalBrief reported that pharma giant Sanofi was ordered by a French court to pay more than €400 000 in damages to a family whose child suffered from a form of autism caused by Valproate, saying the drugmaker failed to inform about known side-effects.
The report said that at the time, French health authorities believed the drug was responsible for deformities in between 2 150 and 4 100 children, and neuro-developmental defects in up to 30 400 children.
Last week, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended that treatment for male patients with valproate should be started and supervised by a specialist in managing epilepsy, bipolar disorder or migraine.
Doctors should also explain to patients the potential risks and discuss the need for effective contraception for them and their female partners, the committee said.
The recommendations suggest the treatment be reviewed regularly to ensure it remains the most suitable medication, particularly when the patient is planning to conceive a child.
In reaching its conclusions, the committee had considered a post-authorisation safety study examining the association between paternal valproate treatment and neurodevelopmental disorders, including autism spectrum disorder and congenital malformations, among offspring in Denmark, Norway and Sweden.
The data showed that around five in 100 children born to fathers treated with valproate three months before conception had a neurodevelopmental disorder, compared with around three in 100 born to fathers treated with the alternative drugs, lamotrigine or levetiracetam.
No difference in the risk for congenital malformations was seen between the two groups.
ENEPP article – EUPAS34201(Open access)
Medscape article – Europe Tightens Valproate Treatment Rules (Open access)
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Sanofi ordered to compensate for epilepsy drug’s autism side-effect in pregnancy
UK medicines’ regulator investigates unsafe epilepsy drug being given to pregnant women
Warnings on side effects of epilepsy drug came 40 years too late