Other safety alerts

The United Kingdom: Safety of valproate – new study on risks in children of men taking valproate

Medicines and Healthcare products Regulatory Agency (MHRA) announces that as part of its ongoing monitoring of valproate safety, MHRA continues to rigorously review all emerging data on valproate. This includes a new study on outcomes in children whose fathers took valproate at the time of conception commissioned by the European Medicines Agency.

Sanofi has recently informed MHRA of errors in the study that may impact the results. As a result, the researchers from the original study are conducting a full re-analysis before any final conclusions can be drawn.

The government’s expert scientific body, the Commission on Human Medicines (CHM), has advised that further guidance in respect of risks in children of men taking valproate should be based upon data that are accurate and complete. As soon as the revised study analysis is available, it will be carefully re-assessed by the MHRA. Any further guidance will be communicated to patients and healthcare professionals as soon as possible.

In December 2022, in light of data showing ongoing exposure to valproate in pregnancy, as well as growing information about potential risks in male patients from preclinical studies and data on infertility, the CHM recommended strengthened safety measures for valproate. The implementation of these new measures has been carefully considered by the CHM’s Valproate Implementation Group.

Further communications on the new safety measures will be issued in due course. No action is currently needed from patients. No one should stop taking valproate without advice from their healthcare professional.

Please refer to the following website in MHRA for details: http://www.gov.uk/government/news/safety-of-valproate-new-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 the risk of NDDs in children after paternal exposure to valproate.

Related news on the risks of NDDs in children after paternal exposure to valproate was previously issued by Singapore Health Sciences Authority (HSA), and was posted on the Drug Office website on 22 Mar 2023. Letters to inform local healthcare professionals were issued by the DH on the same day. As the MHRA’s review is ongoing, the DH will remain vigilant on the conclusion of the review and any safety update of the drugs issued by other overseas drug regulatory authorities.

Ends/Thursday, Aug 17, 2023
Issued at HKT 16:00

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