01 December 2009
Finasteride is a medicine used in men to treat benign prostatic hyperplasia (an enlarged prostate gland) and hair loss.
A Europe-wide review of information from clinical trials, published literature and reports of adverse drug reactions has concluded that an increased risk of male breast cancer associated with finasteride use cannot be excluded.
This report summarises the data and conclusions from the review.
This safety issue has also been highlighted in the December 2009 issue of Drug Safety Update (page 3) (403Kb).
This report presents the evidence that was available when the regulatory decision was made, showing a ‘snapshot’ of the clinical landscape at the time. However, any advice in this report remains current unless it is superseded by a more recent report (where relevant, this is indicated).