Freedom of Information request (FOI 22/924)
Published 17 January 2024
© Crown copyright 2024
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-26-september-2022/freedom-of-information-request-foi-22924
FOI 22/924
27th September 2022
Dear
Thank you for your information request, dated 24 August 2022, where you asked for:
- A copy of the letter the Medicines Control Agency sent to Sanofi on January 18 2000.
- A copy of the letter the Medicines Control Agency sent to Sanofi on 22 July 2002.
- A copy of any communication sent by the Medicines Control Agency with prescribers and health professionals about the potential teratogenic risks of sodium valproate and other AEDs from July to December 2002.
I can confirm that we have searched the electronic archive held by the Medicines and Healthcare products Regulatory Agency and that we do not hold copies of letters from the Medicines Control Agency to Sanofi dated January 18 2000 and 22 July 2002. We do not have a record of any communication sent by the Medicines Control Agency to prescribers and health professionals about the potential teratogenic risks of sodium valproate and other AEDs between July to December 2002. However, I attach for your information, a copy of the Medicines Control Agency bulletin “Current Problems in Pharmacovigilance” which was sent to healthcare professionals across the UK in September 2003 and includes an Article on page 6 titled ‘Sodium valproate and prescribing in pregnancy’.
If you have a query about the information provided, please reply to this email
If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk
Please remember to quote the reference number above in any future communications.
If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:
Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
Yours sincerely,
Safety and Surveillance