UK: Medicines and Healthcare products Regulatory Agency (MHRA)
Mail+ announces that the UK’s Medicines and Healthcare Products Agency (MHRA) will launch a safety review of finasteride (no official link available as of March 4, 2023) – March 4, 2023.
• since finasteride has been marketed there have been a number of spontaneous adverse drug reaction reports suggesting a possible link to depression, and in rare cases, suicidal thoughts
• advise patients to stop finasteride 1 mg (Propecia) immediately if they develop depression and inform a healthcare professional
• be aware that the product information for finasteride 5 mg (Proscar) already lists depression as a possible adverse reaction
Finasteride: potential risk of male breast cancer – 11 Dec 2014
Medicines and Healthcare Products Regulatory Agency, United Kingdom. Finasteride and the risk of male breast cancer. December 2009. Accessed July 16, 2022.
Public Assessment Report – Finasteride 1 mg – 15 Jul 2009. Section 4.8 notes: “Persistence of erectile dysfunction after discontinuation of treatment with PROPECIA has been reported in post-marketing use.”