Freedom of Information request on all internal emails in regards to a syndrome known as “Post Finasteride Syndrome” from 2001 to May 2021 ( FOI 21-630)
Published 29 December 2021
© Crown copyright 2021
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-15-july-2021/freedom-of-information-request-on-all-internal-emails-in-regards-to-a-syndrome-known-as-post-finasteride-syndrome-from-2001-to-may-2021-foi-21-630
15th July 2021 FOI 21/630 Dear
Thank you for your email dated 15 June 2021 where you requested the following:
“all internal emails in regards to a syndrome known as “Post Finasteride Syndrome” caused by the drug Finasteride on behalf of the freedom of information act (FOAI) from the dates of 2001 to May 2021.”
We have searched our records and attached all relevant emails. Redactions have been made under Section 40 of the FOI Act, the names of employees below the grade of Senior Civil Servant (SCS) have been withheld. This is because they are normally not responsible for high profile work and would not reasonably expect their personal details to be in the public domain. As a result, the releasing of their names would not, in our view, be fair or reasonable. We have also made redactions under Section 35 - formulation of government policy and Section 41 – information provided in confidence, in this case by patients or families of patients. Information provided to us in confidence, with the expectation that it will not be released, is exempt from disclosure under the FOI Act.
Please note some emails were picked up when our records were searched for correspondence containing the term “post finasteride syndrome” however the sections containing the term have since been redacted in line with the above explanation. Nevertheless, we have still included these emails in this response.
Finasteride 5 mg (marketed as Proscar) has been available since 1992 for the treatment of benign prostatic hyperplasia (BPH) and for the prevention of urologic events to reduce the risk of acute urinary retention as well as to reduce the risk of surgery including transurethral resection of the prostate and prostatectomy. Finasteride 1 mg (marketed as Propecia) has been available since 1997 for the treatment of male pattern hair loss. In line with other regulators worldwide the MHRA considers that based on the currently available data on quality, safety, and efficacy the balance of benefits and risks of finasteride is positive. However, all effective medicines can cause side effects in some people, and these are described in product information for healthcare professionals (the summary of product characteristics) and patients (patient information leaflet, provided in each pack). Unfortunately it is not usually possible to predict which patients will experience such side-effects. Therefore, the risk of possible side effects of every medicine must be weighed against its potential benefits in each individual.
I hope the information provided is helpful, but 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.
Yours sincerely, FOI Team, Vigilance and Risk Management of Medicines Division