Further information on Propecia (Finasteride 1mg)

MHRA drug safety advice: Finasteride and potential risk of male breast cancer

Drug Safety Update December 2009

Up to November 2009, 50 cases of male breast cancer have been reported worldwide with 5mg finasteride (Proscar®) and three cases with the 1mg dose (Propecia®). The overall incidence of male breast cancer in clinical trials for  finasteride 5mg was not significantly increased: 7.8 per 100 000 patient-years for patients exposed to >1 year of treatment vs. 8 per 100,000 patient-years for those not exposed to the drug. The mechanism of action of finasteride leads to decreases in DHT levels that are accompanied by increases in testosterone and oestradiol levels; and although no change in testosterone: oestradiol ratio is observed, this could have implications for a potentially increased risk of breast cancer. A Europe-wide review of clinical trial data, ADR reports and published literature has concluded that an increased risk of male breast cancer with finasteride use cannot be excluded therefore a warning on this risk will be included in the product information. Patients experiencing any changes in their breast tissue such as lumps, pain, or nipple discharge, should be advised to see their doctor promptly.

MSD Merck Sharp & Dohme warning about internet sales of Propecia tablets

MSD, November 2005

MSD has issued a warning that products claiming to be Propecia® are advertised on some internet sites (hosted on servers based outside the UK) as available for UK patients to buy without a prescription. The company has strongly advised all patients only to purchase this product from licensed pharmacies.

Following consultation with the MHRA, MSD is issuing a patient safety announcement in carefully selected national and regional press and consumer lifestyle magazines with the following message:

Counterfeiting of 'lifestyle' medicines sold on the internet is a growing problem and buying medicines on the internet is risky. Prescription-only medicines should only be taken after obtaining a prescription following a consultation with a healthcare professional. You should only buy prescription-only medicines such as Propecia at a retail pharmacy or from a reputable online pharmacy.

MSD UK has launched a website for patients who wish to find out more information on counterfeit medicines, including how to identify a genuine pack of Propecia.