Other safety alerts
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| The United Kingdom: Valproate: re-analysis of study on risks in children of men taking valproate |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces an update on a retrospective observational study on the risk to children born to men who took valproate in the 3 months before conception and on the need for the re-analysis of the data from this study before conclusions can be drawn.
The MHRA has kept under close review the possibility of risks to children associated with paternal exposure to valproate (in other words, whether a child could be affected if a father was taking valproate). Two studies were conducted by researchers in 2013 that did not find evidence of an increased risk to children with paternal use of epilepsy medicines, but the studies had limitations. As part of the outcome of the 2018 European review of valproate, a new retrospective study was requested from the marketing authorisation holders to examine this risk.
The study report submitted to the MHRA and to other regulatory authorities suggested an increased risk of neurodevelopmental disorders in children whose fathers took valproate during the 3-month period before they were conceived compared to children whose fathers had taken the antiseizure medicines lamotrigine or levetiracetam. However, the MHRA was subsequently informed of errors in the study that may impact on the results. A full re-analysis is required before conclusions can be drawn. As soon as the revised study analysis is available, it will be re-assessed by the MHRA.
No action is currently needed from patients. No one should stop taking valproate without advice from their specialist.
Advice for healthcare professionals:
- The MHRA continues to rigorously review all emerging data on valproate-containing medicines including findings from a retrospective observational study suggesting an increased risk of neurodevelopmental disorders in children whose fathers took valproate in the 3 months before conception, compared to those whose fathers took lamotrigine or levetiracetam.
- However, errors have been subsequently identified in the study that may impact on the results; a full re-analysis is required before conclusions can be drawn.
- As soon as the revised study analysis is available, it will be carefully re-assessed by the MHRA, and any further guidance will be communicated to patients and healthcare professionals as soon as possible.
- For female patients, continue to follow the existing strict precautions related to the known and significant harms of valproate in pregnancy.
- General practitioners and pharmacists should continue to provide repeat prescriptions for valproate; patients currently taking valproate must be advised not to stop taking it unless they are advised by a specialist to do so.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/valproate-re-analysis-of-study-on-risks-in-children-of-men-taking-valproate
In Hong Kong, there are 10 registered pharmaceutical products containing valproate. All products are prescription-only medicines. So far, the Department of Health (DH) has received 15 cases of adverse drug reactions related to valproate, but these cases were not related to neurodevelopmental disorders in children after paternal exposure to valproate.
Related news on the risk of neurodevelopmental disorders in children after paternal exposure to valproate was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 22 Mar 2023, with the latest update posted on 17 Aug 2023. Letters to inform local healthcare professionals were issued by the DH on 22 Mar 2023. The DH will remain vigilant on safety update of the drug issued by MHRA and other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Thursday, Aug 31, 2023
Issued at HKT 16:00
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