Interesting Stats from Finasteride FDA Q&A (April 2012)

[BottleRocket]

Here are a few statistics from a Q&A released by the FDA regarding the persistent sexual side effects of Finasteride. The entire release can be viewed at:

http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm299754.htm

Propecia: In the span of 13 years (1998-2011), 59 cases of persistent sexual dysfunction lasting longer than three months after drug discontinuation were reported to the FDA's Adverse Events Reporting System (AERS).

Proscar: In the span of 18 years (1992-2010), 131 cases of erectile dysfunction and 68 cases of decreased libido lasting longer than several weeks after drug discontinuation were reported to the FDA's worldwide safety database.

I personally thought the number of adverse effect reports would have been higher given that:

1) Lawyers attempting to sue Merck encouraged potential clients to report their adverse effects to the FDA in order to strengthen their case. (Lawyers were hoping for enough reports to warrant a black box warning label for Propecia.)

2) In 2011, Merck took down the Propecia website and displayed a message encouraging anyone with adverse effects to submit a report to the FDA.

3) Propeciahelp.com has over 2000 members.

4) You can submit an adverse effect report to the FDA online.

Bottom Line: After approximately 20 years of reviewing adverse effect reports submitted to their database, as of April 2012, the FDA is confident that Finasteride is both safe and effective for treating male pattern baldness and an enlarged prostate.

[Maradona]

Here are a few statistics from a Q&A released by the FDA regarding the persistent sexual side effects of Finasteride. The entire release can be viewed at:

http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm299754.htm

Propecia: In the span of 13 years (1998-2011), 59 cases of persistent sexual dysfunction lasting longer than three months after drug discontinuation were reported to the FDA's Adverse Events Reporting System (AERS).

Proscar: In the span of 18 years (1992-2010), 131 cases of erectile dysfunction and 68 cases of decreased libido lasting longer than several weeks after drug discontinuation were reported to the FDA's worldwide safety database.

I personally thought the number of adverse effect reports would have been higher given that:

1) Lawyers attempting to sue Merck encouraged potential clients to report their adverse effects to the FDA in order to strengthen their case. (Lawyers were hoping for enough reports to warrant a black box warning label for Propecia.)

2) In 2011, Merck took down the Propecia website and displayed a message encouraging anyone with adverse effects to submit a report to the FDA.

3) Propeciahelp.com has over 2000 members.

4) You can submit an adverse effect report to the FDA online.

Bottom Line: After approximately 20 years of reviewing adverse effect reports submitted to their database, as of April 2012, the FDA is confident that Finasteride is both safe and effective for treating male pattern baldness and an enlarged prostate.

This world is corrupt and there are drugs with ****ed up sides in the past that have been taken out the market.

**** the FDA and Merck. Why did they miss all the other sides?

[BottleRocket]

Hi Maradona, I agree that corruption exists in the world. My post isn't meant to defend either side. I'm simply pointing out that given the number of complaints in forums, the media attention, etc, I'm surprised that there haven't been more adverse effect reports submitted to the FDA by consumers in the last 20 years. If there were say, 2,000 reports of persistent sexual dysfunction for Propecia (rather than 59), perhaps the FDA would have taken Finasteride off the market (for male pattern baldness).

[Maradona]

Hi Maradona, I agree that corruption exists in the world. My post isn't meant to defend either side. I'm simply pointing out that given the number of complaints in forums, the media attention, etc, I'm surprised that there haven't been more adverse effect reports submitted to the FDA by consumers in the last 20 years. If there were say, 2,000 reports of persistent sexual dysfunction for Propecia (rather than 59), perhaps the FDA would have taken Finasteride off the market (for male pattern baldness).

The FDA are not angels or run by God ! They are people like you and me.

If I was in the FDA signing papers for drug approvals and I was offered to get my hair back or money in their case If I signed a drug that will have a minority suffering frmo permanent ****ed up sides. I might think about it. Wouldn't you? Wait you'll answer no but you get my point.

[gmonasco]

If I was in the FDA signing papers for drug approvals and I was offered to get my hair back or money in their case If I signed a drug that will have a minority suffering frmo permanent ****ed up sides. I might think about it. Wouldn't you?

If you're suggesting that people who work for the FDA are human and therefore could be susceptible to bribes, yes that may be the case. But you can't get a drug approved simply by buying off one person at the FDA -- a whole lot of different people at multiple levels are involved in the approval process, all of whom would have to be secretly paid off to get an otherwise unacceptable drug into the market.

[Maradona]

If you're suggesting that people who work for the FDA are human and therefore could be susceptible to bribes, yes that may be the case. But you can't get a drug approved simply by buying off one person at the FDA -- a whole lot of different people at multiple levels are involved in the approval process, all of whom would have to be secretly paid off to get an otherwise unacceptable drug into the market.

It's easy to bypass a drug like this one especially when it's a very very minority of PFS users and having a different application other than MPB. Not saying they were all bought up but any small "boost" would definitely help a bit.

Who knows? Making it come to market sooner?

[BottleRocket]

Rather than going on a tangent, I'd like to stay on the topic of this thread, which is a discussion pertaining to the very low number of persistent sexual side effects reports submitted by the public to the FDA's database (59) compared to the seemingly high number of reports on forums (thousands).

[gmonasco]

It's easy to bypass a drug like this one especially when it's a very very minority of PFS users and having a different application other than MPB.

The "different application" is irrelevant. The manufacturer has to perform separate clinical trials and seek separate FDA approval for each disease or condition for which a drug is marketed. Finasteride could have been approved for treating prostate conditions but still rejected as a hair loss treatment if it was found to be unsafe and/or ineffective in the latter case.

[gmonasco]

Rather than going on a tangent, I'd like to stay on the topic of this thread, which is a discussion pertaining to the very low number of persistent sexual side effects reports submitted by the public to the FDA's database (59) compared to the seemingly high number of reports on forums (thousands).

I'd hazard a guess that far more finasteride users know about and use hair loss forums than they do the FDA's serious adverse event reporting procedures.

[Maradona]

The "different application" is irrelevant. The manufacturer has to perform separate clinical trials and seek separate FDA approval for each disease or condition for which a drug is marketed. Finasteride could have been approved for treating prostate conditions but still rejected as a hair loss treatment if it was found to be unsafe and/or ineffective in the latter case.

Looks like you need to do some research.

[SoothSayer]

To respond to a couple of your points:

1. The FDA analysis drew a cutoff at April 2011 for analyzing observations. This was really before the sexual side effects issue had received any significant media coverage so many people didn't know about the effects yet. Since this cut-off (I have done my own analysis) the reporting rates have been growing exponentially. In the year following the cutoff, about 50 additional reports had been submitted that should have been included in the FDA analysis. The FDA also had to eliminate a lot of reports due to incomplete information since the database is very poorly maintained. A lot of reports had missing treatment dates, concomitant medications, adverse event dates etc and many of these were thrown out because the FDA analysis was almost as conservative as it could be.

2. The FDA website is actually quite a nuisance. Many people have tried to submit their reports and were deterred due to the complicated nature of the site and the ambiguous information that is requested. Chrisis is a member here who tried to submit a report but he gave up after a couple of days.