FDA WARNING OF PERSISTENT SEXUAL DYSFUNCTION WITH PROPECIA

[braziliandude]

April 12, 2012

Yesterday, the FDA added new adverse event language in the postmarketing experience section of the Propecia product label (see attached letter and product label revision) that warns of:

“sexual dysfunction that continued after discontinuation of treatment, including erectile dysfunction, libido disorders, ejaculation disorders, and orgasm disorders; male infertility and/or poor seminal quality (normalization or improvement of seminal quality has been reported after discontinuation of finasteride); testicular pain.”

In Questions and Answers: Finasteride Label Changes (

fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm299754.htm) posted today on the FDA website,

FDA states that it “has notified healthcare professionals who would normally prescribe finasteride products—dermatologists, family practice professionals, internists and urologists—about FDA’s review of postmarketing reports and the label changes.”

FDA has required similar new warnings about persistent sexual dysfunction to be included in a parallel Proscar product label change.

THIS IS HUGE!!! Finaaaaalllly

[bostonusa2009]

It’s a step in the right direction, but there is still no mention of the other damaging side effects done to the endocrine system from this drug. No mention of vision problems, stomach problems, brain fog, joint problems, memory problems, loss of sensation in genitals, muscle loss, sleep problems, dental problems. I’m sure I’m missing some others as well.

[braziliandude]

Rome wasnt build in a day, one step at a time…just to have the FDA using the word PERSISTENT is all ready HUGE…after reading persistent all the words just went blur…this is trully the happiest day sine this wholke nighrmare began

[Len]

the drug companies are the devil, and the fda is their whore

fuck the fda

[BP7667]

Thats good news. About time they freakin did something, and they should probably do a hell of lot more. Did you read the part with the Q&A?

Q7. I am currently taking Propecia or Proscar. What should I do?

A7. [b]If you have questions or concerns, you should consult your health care provider to discuss the risks and benefits of the medication as they specifically apply to you. Do not stop taking your medication without first consulting with your health care provider.

FDA believes that finasteride remains a safe and effective drug for its approved indications. Healthcare professionals and patients should consider this new label information when deciding the best treatment option. [/b]

Ok so they still say its safe and urge people not to stop using this w/o talking to their doc. Thats insane when there are other drugs docs can prescribe for BPH (Flomax), and anyone taking this for alopecia knowing its potential side effects is crazy. They just need to boot this shit from the market and be done with it, its not safe in the least who knows what this crap even did to my liver such that I have liver pain all the time now at 29… what is that going to do to me long term? Hell knows.

[BP7667]

philly.com/philly/health/HealthDay663734_20120412_Baldness_Drug_May_Cause_Sexual_Side_Effects__FDA.html?cmpid=138896554

Dr. Anthony D’Amico, chief of genitourinary radiation oncology at Brigham and Women’s Hospital in Boston, said Thursday that the revised labels contain “an important message that people need to hear.”

“Particularly because Propecia is used by 20- and 30-year-olds for hair loss and these are people of childbearing age, so if they are getting issues with fertility that a big issue,” he said.

In a statement released Thursday afternoon, Merck said:

“Merck believes that Propecia and Proscar are generally well tolerated and effective for their respective intended uses in accordance with their approved product labeling. In addition, please note that a causal relationship between the use of Propecia or Proscar and continued sexual dysfunction after discontinuation of treatment has not been established.”

Here it is again with their well tolerated BS. As far as a causal relationship, I think we are the justification for that, not our fault the medical community took years to recognize this problem. Besides the sexual dysfunction what about a complete hormonal crash and endocrine system destruction? Who needs to establish this? How many scientists need to look at us and see a bunch of guys, fine one day then take finasteride a few times and your body goes to hell?

[BP7667]

Oh and it finally got some attention on one of the major national news outlets.

foxnews.com/health/2012/04/13/sexual-side-effects-added-to-merck-drug-labels/

In my opinion now would be a good time to start lambasting these guys with phone calls and emails. Tell these news outlets that that Merck may not admit their drug causes problems but they are well aware of the number of men suffering.

[braziliandude]

i just cannot believe this…the time everyone was waiting…!! now theres proof this is real. no need look like a maniac anymore…im so relified

[BP7667]

Yes its a very good thing. But I still do not think some doc’s will be convinced until a million dollar study puts its stamp of approval on it.

[Second_Amendment]

The FDA sidestepped the more horrific reactions like shrinkage and numbness and instead listed “orgasm disorders” (whatever that is). It’s obvious whose side the FDA is on.

[BP7667]

@Second Amendment

The FDA sidestepped the more horrific reactions like shrinkage and numbness and instead listed “orgasm disorders” (whatever that is). It’s obvious whose side the FDA is on.

And don’t forget the mental sides, which will really fuck you up… I remember sitting around not being able to sleep going crazy with anxiety for months when I first came off, then if I did lie down to try to sleep freakin muscle spasms all night long.

The FDA is also covering its own back here they don’t want to freely admit they put a dangerous drug on the market. But hell, one step in the right direction. At least they are now going to notify doc’s who are writing scripts for this shit. They should also notify Psychiatrists too.

BTW now on CBSnews and Time picked it up too.

cbsnews.com/8301-504763_162-57413756-10391704/fda-adds-sexual-side-effects-warning-to-baldness-drug-propecia/

healthland.time.com/2012/04/13/fda-adds-sexual-side-effects-to-propecia-and-proscar-labels/

[Second_Amendment]

@Broken_Pecker

@Second Amendment

The FDA is also covering its own back here they don’t want to freely admit they put a dangerous drug on the market. But hell, one step in the right direction. At least they are now going to notify doc’s who are writing scripts for this shit. They should also notify Psychiatrists too.

My bet is that it’ll take a while before docs give warning and update the PPI. (Who would take this shit given 10% of the side effects are now listed). I was prescribed this poison in May 2011, and was given the old PPI. My doc mentioned nothing about the new warnings like depression, permanent ED, male breast cancer, etc.

[ben760]

they did not include changes in penis (shrinkage, narrowing, wrinkling) which most of us got because if they did that’s the end of propecia.

[Len]

the fda is loyal to merck… in my opinion they only made these minor changes to cover their own asses with all of the law suits now coming out … the fda are scum

[boston332]

@ben760

they did not include changes in penis (shrinkage, narrowing, wrinkling) which most of us got because if they did that’s the end of propecia.

Yes, and their exposure on the law suits would be alot greater. Mine is a shrunken mess and it’s definately the most depressing part of this whole thing.

[Len]

the fda still says they think finasteride is “safe and effective” … that says it all … and of course they left out the most devestating side effects … genital numbness, genital shrinkage, peyronnes disease, not to mention the nuerological damage and physical destruction of our bodies … the fda is just as bad, they are only making the changes so it appears they did something to help… they are all scum