Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.
Finasteride is used to treat benign prostatic hyperplasia (an enlarged prostate gland) and hair loss in men.
A Europe-wide review of clinical trial data, adverse drug reaction reports and published literature has concluded that an increased risk of male breast cancer associated with finasteride use cannot be excluded. A warning on the risk of male breast cancer will be included in the product information for finasteride
The following Public Assessment Report (published December 2009) presents a summary of the data and conclusions from the review.
Dowload the Public Assessment Report
(294Kb)
Go to the December issue of Drug Safety Update for further reading.
