Report - U.K. Adverse Drug Reactions to Finasteride

Report - U.K. Adverse Drug Reactions to Finasteride.

View attached PDF.
Report - Finasteride - UK Adverse Reaction data.pdf (18.6 KB)

From British Medical Journal, listing Finasteride for BPH:
bmj.bmjjournals.com/cgi/reprint/ … 0/1042.pdf

The most common adverse events associated with finasteride in the first year were decreased libido (6%), impo­tence (8%), and decreased ejaculation (4%).

The information quoted above is nothing new.
Aren’t these findings the EXACT same findings in the Proscar 5 mg study?
According to the Proscar study:
8.1% Impotence
6.4% decreased libido
3.7% decreased volume of ejaculate

The study referenced in the previous two posts are talking about finasteride 5 mg…NOT 1 mg (propecia).

Looking into this further, it seems the BMJ did round off the numbers in their document. Those are the same numbers used in the Proscar PLESS trial, as you correctly pointed out, which was 5mg… hence BMJ referrencing use of Finasteride for BPH.

BTW, those stats are included in Merck’s PDR, here (page 3):
merckfrosst.ca/assets/en/pdf … 2_06-E.pdf

Nonetheless those side effects did occur in a certain portion of men, at least in the 1st year of use in the trial. Wether one wants to believe the study that there was no difference between placebo by year 2, is another story… certainly the men on this site will disagree, especially considering Merck’s involvement.

For example, notice the pharmaceutical connections of the authors of the following, which reference the PLESS study:
sciencedirect.com/science?_o … 678ba#cor1

Scroll to the bottom, notice the author contact points:

Financial interest and/or other relationship with Merck.
Financial interest and/or other relationship with Glaxo, Synthelabo, Abbott, U.S. Surgical, Vida Med, Dornier, Urologix and Pfizer.
Financial interest and/or other relationship with Serono, Unimed, Biotek, Wyeth Ayerst, Organon and Smith Kline.
Merck, West Point, Pennsylvania.

BTW, here’s another meta-analysis done on all Finasteride studies:
pubmedcentral.nih.gov/articl … tid=140032

Specific adverse effects
The most commonly reported adverse effects were impotence, decreased libido and ejaculation disorder. Definitions of these adverse effects were generally not provided in the trials.”

"Significantly more men reported any sexual dysfunction, decreased libido, impotence, or ejaculation disorder with finasteride than with placebo at 12 months of treatment. Incidence rates ranged between 2–14% with finasteride and 0.6–7% with placebo, and NNHs for particular adverse events ranged between 14 and 55 (Table 4). This means, for instance, that for every 24 men treated with 5 mg finasteride for 12 months impotence would occur in one in whom it would not have occurred with placebo."


Oh and by the way, more food for thought on Merck’s involvement with PLESS…

scholar.google.com/scholar?q=ple … a=N&tab=ws

^^ scroll to bottom and click “Sexual Adverse Events From Finasteride Most Prominent in First Year CME” (Medscape, 2nd link from bottom). Notice midway through article:

Merck & Co., Inc., supported this study and funded or employed several of its authors.

Urology. 2003;61:579-584

Updated UK Adverse Effects file, current up to April 2008, from UK’s MHRA Yellow Card reporting program.

mhra.gov.uk/Safetyinformatio … geNumber=2

It lists, amongst others, Peyronie’s Disease (penile fibrosis) as a category.
UK MHRA - Finasteride Adverse Reactions - Up to April 2008.pdf (98.3 KB)