FOI release

Freedom of Information request on statins (FOI 21-064)

Published 24 March 2021

Thank you for your email dated 13th January 2021, where you requested:

“Is it possible to send me any information on statins and incidence of psychiatric disorder or behavioural symptoms reported to this e-mail address. I note there have been some case reports in USA.”

Unfortunately, the information is exempt from release under Section 21 – Information accessible by other means: the information you have requested is already in the public domain. ADR data for medicines is available on our website within Interactive Drug Analysis Profiles (iDAP). iDAPs allow users to view all adverse reactions reported for a particular drug substance and also filter the reports so the charts and tables display subsets of the data, such as limiting to just males or females for example. There is guidance at the bottom of each iDAP page around the interpretation of this information provided on the website which is important to read and understand. It is particularly important to note that reports are not confirmed side effects to a medication and that incidence cannot be derived since a number of factors influence reporting of ADRs.The iDAPs for statins can be found via the following link: https://yellowcard.mhra.gov.uk/iDAP/

The MHRA continuously monitors the safety of medicines such as statins through a variety of pharmacovigilance processes including the Yellow Card Scheme. As part of our signal detection processes all adverse reaction reports received by the Yellow Card Scheme are individually assessed and cumulative information reviewed at regular intervals. Any emerging evidence relating to possible risks associated with medicines, is carefully reviewed and, if appropriate, regulatory action would be

taken if any serious risks were confirmed. I hope the information provided is helpful; however, 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 of this response; and can be addressed to this email address.

Please remember to quote the reference number above in any future communications.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division

The MHRA information supplied in response to your request is subject to Crown copyright. The FOIA only entitles you to access to MHRA information.

For information on the reproduction or re-use of MHRA information, please visit

https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhrainformation

If you have a query about this email, please contact us. If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please write to the Communications Directorate, 4-T, Medicines and Healthcare products Regulatory Agency, (via this email address). After that, if you remain dissatisfied, you may ask the Information Commissioner at:

The Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

Copyright notice

The information supplied in response to your request is the copyright of MHRA and/or a third party or parties, and has been supplied for your personal use only. You may not sell, resell or otherwise use any information provided without prior agreement from the copyright holder.