FDA Advisory Committee and Merck discussing Propecia

[kreator95]

seems like this was the meeting when the drug was approved. This files got all the dialogue at the meeting.

fda.gov/ohrms/dockets/ac/97/ … 3352t1.rtf

fda.gov/ohrms/dockets/ac/97/ … 3352t1.pdf

Below is the link for proscar information by merck:

accessdata.fda.gov/drugsatfd … 033lbl.pdf

This states the following:

Finasteride is a competitive and specific inhibitor of Type II 5α-reductase with which it slowly forms a stable enzyme complex. Turnover from this complex is extremely slow (t½ ∼ 30 days). This has been demonstrated both in vivo and in vitro. Finasteride has no affinity for the androgen receptor. In man, the 5α-reduced steroid metabolites in blood and urine are decreased after administration of finasteride.

“stable enzyme complex”. what is this

In healthy male volunteers treated with PROSCAR for 14 days, discontinuation of therapy resulted in a return of DHT levels to pretreatment levels in approximately 2 weeks. In patients treated for three months, prostate volume, which declined by approximately 20%, returned to close to baseline value after approximately three months of discontinuation of therapy.

I heard this for the 1st time that it can take upto three months to recover.

[Mew]

Yes, this was posted previously in the Finasteride Studies section.

propeciahelp.com/forum/viewtopic.php?t=180

[bostonusa2009]

In healthy male volunteers treated with PROSCAR for 14 days, discontinuation of therapy resulted in a return of DHT levels to pretreatment levels in approximately 2 weeks. In patients treated for three months, prostate volume, which declined by approximately 20%, returned to close to baseline value after approximately three months of discontinuation of therapy.

I heard this for the 1st time that it can take upto three months to recover.
[/quote]

Kreator,

There are hundreds of men on this forum that have suffering been suffering for years, foget about 3months. That is BS created by Merck.

[anonnn1]

Yes…this is complete BS from Merck.

Merck is an unethical company led by greedy self-centered executives who only care about making more money for their corporation, and increasing shareholder value by destroying people’s lives…

Richard T. Clark, CEO of Merck, should be held criminally and civilly accountable for their actions.

CHANGE THE LABEL ON THE DRUG! THE COMPANY IS DESTROYING LIVES!

[Mew]

Guys, when they said 3 months they meant prostate volume.

In patients treated for three months, prostate volume, which declined by approximately 20%, returned to close to baseline value after approximately three months of discontinuation of therapy.