Promotion of Epilim (sodium valproate) by Sanofi
Published 27 August 2021
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1. SUMMARY REPORT FOR PUBLICATION
1.1 May 2021 Promotion of Epilim (sodium valproate) by Sanofi
A member of the public contacted MHRA to raise concerns about a Sanofi website for healthcare professionals called the Valproate Knowledge Centre. Sanofi hold a marketing authorisation for sodium valproate under the brand name Epilim. The complainant did not consider that the patient viewpoint was adequately considered in the material and questioned the suitability of the format. They were concerned that data on the website from studies was selective in nature, focussed on effectiveness rather than balancing against the risks of treatment, especially for women and girls of childbearing age, and that the importance of some of the information felt minimised or lacking in advice or detail. The complainant also said that patients were easily able to access an area for doctors only, and that it was not clear from the web address that it was a Sanofi website.
MHRA considered that the website was appropriately targeted towards an audience of healthcare professionals. MHRA contacted Sanofi regarding the concerns and asked them to review their website, including to ensure it was brought up to date with the latest information to support safe use of valproate. Sanofi has considered the issues raised by the complainant and MHRA, and decided to withdraw the website in its entirety as the relevant safety materials are available on alternative appropriate digital platforms. As the website was withdrawn from use, MHRA took no further action but reminded Sanofi of the importance of keeping information up to date.