Epilim warning for would-be fathers

“Use of sodium valproate at the time of conception by people who are able to father children has been linked to a potential increased risk of neurodevelopmental disorders in children”

A potential risk of neurodevelopmental disorders in children whose fathers were taking sodium valproate at the time of conception has sparked a warning to healthcare providers.

Medsafe today issued an “alert communication” warning about the drug, which goes by the brand name Epilim in New Zealand. It is used to treat epilepsy and bipolar disorder.

Use of sodium valproate at the time of conception by people who are able to father children has been linked to a potential increased risk of neurodevelopmental disorders in children, compared to those who took lamotrigine/levetiracetam, a retrospective observational study suggests.

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The study used electronic medical records in three Nordic countries to examine the association between paternal exposure to different anti-epileptic drugs at the time of conception and the risk of neurodevelopmental disorders. It identified sodium valproate as having a potential increased risk compared to those treated with lamotrigine or levetiracetam.

Due to study limitations, it was not possible to determine which of the studied neurodevelopmental subtypes – autism spectrum disorder, intellectual disability, communication disorder, attention deficit/hyperactivity disorder, movement disorders – contributed to the overall increased risk of neurodevelopmental disorders, the Medsafe alert says.

The Epilim Data Sheets and consumer medicine information leaflets have been updated, and a Dear Healthcare Professional Letter has also been produced, Medsafe says.

Doctors and other healthcare professionals are being advised to inform patients of the increased risk, and to consider alternative treatment options for those wishing to father a child. Clinicians are also being advised to discuss the need for effective contraception when starting the drug and periodically throughout treatment.

Pharmacy Retailing (NZ) Ltd trading as Healthcare Logistics is the New Zealand sponsor on behalf of Sanofi for all Epilim products in New Zealand.

Products include: Epilim EC modified release tablet (200mg and 500mg), Epilim Liquid oral solution (200mg/5mL), Epilim 100 crushable tablet (100mg), Epilim IV Powder for injection with diluent (100mg/mL), and Epilim Syrup (200 mg/5mL).

The Medsafe alert also reminds healthcare professionals it is estimated that up to 30 to 40 per cent of children whose mothers took valproate during pregnancy may have problems with early childhood development.