Potential risk to children of fathers treated with valproate

Sanofi Australia & New Zealand has advised prescribers of new warnings and measures to inform about higher risk of neurodevelopmental disorders (NDD) including autism spectrum disorders in children after paternal exposure to valproate as compared to lamotrigine/levetiracetam. 

Key information:

  • A retrospective observational study on electronic medical records in 3 European Nordic countries indicates an increased risk of NDDs in children (from 0 to 11 years old) born to men treated with valproate at time of conception compared to those treated with lamotrigine or levetiracetam. 
  • The adjusted cumulative risk of NDDs ranged between 5.6% to 6.3% in the valproate group versus between 2.5% to 3.6% in the composite lamotrigine/levetiracetam monotherapy exposure. The pooled adjusted hazard ratio (HR) for NDDs overall obtained from the meta-analysis of the datasets was 1.47 (95% CI: 1.10, 1.96).  
  • Due to study limitations, it is not possible to determine which of the studied NDD subtypes (autism spectrum disorder, intellectual disability, communication disorder, attention deficit/hyperactivity disorder, movement disorders)
  • As a precautionary measure, the prescriber should inform the male patients of this potential risk and consider alternative therapeutic options with the patients. In men initiating or remaining on valproate treatment, the need for effective contraception should be discussed with the patient, at least annually. The prescriber should ensure the male patient has acknowledged the risk and precautions associated with valproate use. 

To reflect this, Product Information has been updated, together with resources for both health professionals and patients

Please remember that any suspected adverse events should be reported to the Therapeutic Goods Administration (TGA), or Medsafe. 

Adverse reactions can also be reported directly to Sanofi: email ae@sanofi.com or phone 02 8666 2123.



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