Big News | Merck Updates Sexual Side Effect Warnings on Propecia Hair Loss Drug Label

[TakingThePlunge]

Until recently, Merck maintained that any side effects from Propecia (finasteride) were temporary. However, recent updates to Propecia's labeling may confirm what some men have suspected all along, Sometimes side effects do not resolve themselves upon discontinuation of the drug.

 

For more on recent changes to Propecia's warning label see, FDA Forces Merck to Change Propecia Hair Loss Drug Label?.

[Bill - Seemiller]

Dave,

 

This is big news. Thanks for reporting on it and posting information about it on this forum.

 

I do think it's strange however, that many Propecia users are having these lasting sexual side effects when you don't hear the same thing from men on Proscar for BPH. Could symptoms be psychooematic or is there some other variable responsible for this?

 

I think it was probably smart for Merck to make modifications to their labels however, I do think that many of the recently reported side effects are a bit blown out of proportion as most hair restoration physicians still feel confident that Propecia is still very safe and effective in treating hair loss.

 

On the other hand, I don't want to minimize those people who've had side effects from the drug. Perhaps some of the men who've experienced side effects from Propecia reading this topic can share their experience.

 

Best wishes,

 

Bill

[aaron1234]

Lawsuit protection anyone?

[Bill - Seemiller]

Does anyone else have any thoughts on this topic?

[Aldebaran]

There aren't enough appropriate studies. The reports and lawsuit forced them to include the possibility. That said, to say that all the cases of serious side effects are psychosomatic is madness. Many of the people having the issues are in cure with serious practitioners and posses test results which show their hormone levels being out of whack. The cause is probably a genetic hypersensitivity. People with predisposition to hypersensitivity have their DHT lowered to practically zero when using finasteride, which it seems triggers a change in gene expression that practically shuts down Testosterone in affected men once they quit the treatment. This has in turn a serious cascade effect on the affected men's psiche and sexual fitness. I still believe that of the few thousands of people registered on propeciahelp.com, at best half or two thirds have the actual "post finasteride syndrome".

[Blake Bloxham]

Thanks for the update, Dave.

[zenmunk]

TakingThePlunge,

 

I've read on one of these threads that you've decided to discontinue finasteride indefinitely. Is that true? If so, how long were you on it? And, how do you feel since stopping?

 

Thanks,

 

z

[NEWHAIRPLEASE]

Bill,

I personally think its a major placebo effect. The power of the mind is unbelievable. I think some people may get it in there head. I'm sure anyone who has had any problem once with impotence will be thinking about it everytime. Again, this is just my opinion!!

[blowdry]

I think the difference could be that Men with BPH have a medical problem so they are put on Proscar versus Men that are normal and use propecia. The prostrate is large so less reduce the DHT to make it smaller vs the prostrate is normal so lets fuck it up................just my take..........................

 

"I do think it's strange however, that many Propecia users are having these lasting sexual side effects when you don't hear the same thing from men on Proscar for BPH. Could symptoms be psychooematic or is there some other variable responsible for this?"

[HARIRI]

I said it once and will say it twice. Finasteride is POISON... Just stick to Minoxidil and saw palmetto or any natural supplement.

[TakingThePlunge]

zenmonk,

 

I took it for about three years. I decided to stop about 5 months ago because I suspected it was causing the cystic acne I was experiencing and also my wife was not comfortable with it since we were considering trying for a baby.

 

During that time I used it, I experienced weaker erections, watery semen and no morning erections. I'd say about two months after stopping everything went back to normal. However, I am a bit worried about the inevitable hair loss I know is coming. I'm continuing Rogaine Foam and Nizoral twice weekly and so far I don't think my hair has thinned.

 

I've thought about starting it again since we have put the baby on hold for now but I'm still not convined that it wasn't contributing to my acne which I am still fighting.

[Sean]

David, I remember writing to your thread about this before as I remember you went off of it. It's great hearing you are no longer facing the 3 side effects you listed and things have gotten better. My blood tests and everything is normal thus far and even reading other users tests and long term use being normal, it reassures me a little bit. I haven't faced the other sides but all this side effect talk along with what Merck has now listed on the label is making me think WTF. Did they just do it to get out of the liability mess or did they actually scientifically confirm this happened permanently in some people?

 

I am still continuing to use it because the response rate along with rogaine foam has been quite high for me and it is evident in my blogs on areas where I have my native hairs. You can actually see the transition from my 1 year pre-op photos to what my non transplanted area of the scalp looks like now. So, I am addicted to this because of the benefit luring me as it gives me what I want greatly (hair) but even moderators like you and some users on the forums have stopped, which is causing some confusion. Many more stopped use or considering after reading the threads about the FDA response to the permanent sexual side effects.

 

For those interested, Merck updated Propecia info on 4/12 here:

http://www.merck.com/product/usa/pi_circulars/p/propecia/propecia_ppi.pdf

 

I wanted your input on Saw Palmetto since I am sure you have come across it a few times. The links I have are just research and study related links to try to understand this and get user or possibly some expert opinion. Not promoting but rather wondering if this actually does do something by analyzing the research available. Some forum members in the past and now have suggested that I take a look at saw palmetto extract as a replacement. There are conflicting reports and news releases about this:

Saw Palmetto Alleviates Prostate Problems - ABC News

 

My own research has been very confusing. Research available is indicating the ingredient Beta Sitosterol which is found in plants may be the thing that inhibits 5 alpha in some patients and these studies are being thrown off because saw palmetto berries may not have the same potency of this material in each dosage as it may be unevenly distributed. So, because supplement quality varies and most high quality saw palmetto berry stocks only contain 1% of beta sitosterol, then some people may have a higher response then those who don't get the same amount in their batch. That is just one reason why the studies seem flawed. Beta Sitosterol also has its own sides and concerns: BETA-SITOSTEROL: Uses, Side Effects, Interactions and Warnings - WebMD

 

Suprisingly, FDA does allow the claim plant sterols, such as beta sitosterol, can reduce Coronory Heart Disease after researchers found that it does reduce cholesterol. They just don't have enough human studies to determine if it does inhibit 5 alpha reductase for androgenic alopecia. Some minor studies suggest a response but that's what's throwing me off.

 

Here is one on humans: A randomized, double-blind, placebo-... [J Altern Complement Med. 2002] - PubMed - NCBI

 

Here is one on hamster prostate: Effect of beta-sitosterol as inhibit... [Proc West Pharmacol Soc. 2003] - PubMed - NCBI

Such animals vs humans are 2 different things. Safety and effective dosing levels based on size of the animal vs human can't be compared.

 

Here are these others that inhibit 5 A R:

Inhibition of steroid 5 alpha-reductase by specifi... [biochem J. 1992] - PubMed - NCBI

 

Inhibition of 5 alpha-reductase activity in hu... [br J Dermatol. 1988] - PubMed - NCBI

 

You can see the timelines of these studies do vary and there are more out there, but they all have different control groups and the studies are just so disorganized or old. It's like a lost cause. No one has really put in enough research or funding to do a thorough in depth study that looks at plant sterols/beta sitosterol and etc on humans by age groups and dosage. A reason could be that they think baldness is cosmetic and determined it is a common accepted condition. It also takes millions of dollars to do it and then you have to go through all the clinical phases and meetings before FDA can endorse it. If I remember reading this correctly, but both Minoxidil and Finasteride were accidental discoveries for hair loss and they were made for other serious conditions. Once the industry found out, they made tons of money off of them for hair and continue to. So, it seems like multiple ongoing research trials for other products & the added costs deter large pharma from pursuing it. They seem to rule out the use of research since they are so concerned of making money for their investors. The only other companies who are currently focusing on hair loss research, such as hair multiplication, hair regrowth, stem cell, etc , are small in size and rely heavily on investor funding and they don't even have full support/hope from the public for the cause.

 

Merck's own manual has somewhat different responses to Saw Palmetto:

 

Saw Palmetto: Medicinal Herbs and Nutraceuticals: Merck Manual Home Edition

 

Saw Palmetto: Dietary Supplements: Merck Manual Professional

 

 

So, some people say it could help but the research out there leaves me wondering if SawPalmetto/BetaSitosterol are causing a placebo effect, if there is inconsistency in material used, low doses preventing a therapeutic effect, or etc.

 

Do you have an opinion about it? Since you have been off of finasteride, have you considered trying saw palmetto/beta sitosterol in exchange for the moment? Or are you really going to just stick it to finasteride and get back on it?

 

By the way, for the acne, have you tried Neutrogena Deep Clean Facial Cleanser and the scrub? I don't think we'll ever find out what is the cause of prolonged acne, too many things can cause it, even stress by itself.

[zenmunk]

zenmonk,

 

I took it for about three years. I decided to stop about 5 months ago because I suspected it was causing the cystic acne I was experiencing and also my wife was not comfortable with it since we were considering trying for a baby.

 

During that time I used it, I experienced weaker erections, watery semen and no morning erections. I'd say about two months after stopping everything went back to normal. However, I am a bit worried about the inevitable hair loss I know is coming. I'm continuing Rogaine Foam and Nizoral twice weekly and so far I don't think my hair has thinned.

 

I've thought about starting it again since we have put the baby on hold for now but I'm still not convined that it wasn't contributing to my acne which I am still fighting.

 

It's good to hear that after 5 months of discontinuation you have experienced no lingering side effects from the meds. I've been taking propecia daily for 13+ years with little side effects. I noticed slightly less semen viscosity way back when, but that's about it. Interestingly, I recently had a semen analysis done (and a battery of other tests) and the results came back completely normal.

 

All of this talk lately of side effects, especially severe ones, which do not resolve after discontinuation of finasteride, and Merck's new labeling, etc. has me somewhat concerned. While my experience on the meds have been good, I worry about how discontinuation might affect my body. I'm not planning on stopping now, but I may someday. I guess there is no way to know until I do it, but the thought is not pleasant. Are you aware of cases where people have had no problems while on finasteride, but developed problems after stopping?

 

Thanks.

[orlhair1]

Sean, great post. Even though I have not had side effects, other than some initial pain early on, I still don't like taking it. I am just not a fan of taking any type of drug for anything other than something that is really critical to your health. This is the first time I have deviated from that in my life. So, I share your interest on this topic. I also plan to talk to Dr. Shapiro about it when I see him for my next surgery in June.

[zenmunk]

Sean,

 

Thanks for the information on SawPalmetto/BetaSitosterol. Food for thought.

 

z

[gasto]

You should have asked me.

 

For acne, there is something infallible, a green tea bag combined with a tablespoon of moisturizer applied on the affected zone every night along with aloe vera and washed out the day after. Give it a week and you'll remember me for the rest of your life.

[Sean]

Orlhair, thanks. I agree. I am not a fan of taking anything other then something for the health. Please let me know if you hear anything.

 

Zen, thanks. It definitely is something interesting. Some that have stopped finasteride have started this natural regimen as an alternative to it. Some swear by it too. So, it makes me think if there are similarities between the two in inhibiting 5 A R.

 

Here are some related filings/information about Merck & Propecia:

Propecia Lawyer | Propecia Side Effects FDA Warning

 

Propecia Lawsuit | Propecia Erectile Dysfunction MDL

 

Propecia Side Effects | Propecia Lawsuits MDL

 

For NY/NJ, there is a judicial panel that was established on April 16, 2012 .

 

People seem to be arguing about permanent sexual issues as well as cognitive issues. So, that's pretty interesting.

[Looq]

I took Propecia for exactly one year and stopped this past March. My hair loss did not cease and I did not see any significant slowing of my hair loss during that year. I definitely noticed a lower sex drive and weaker erections from about 1 week after I started taking the pill and it still continues a month and a half after stopping. It seems like nothing can stop my hair loss, which is fine, I've come to terms with it(mostly), but I REALLY hope these side effects go away eventually.

[TakingThePlunge]

Sean,

 

Sorry for the delayed response. I just only just saw your post. When it comes to "natural" treatments of any kind, I'm normally pretty skeptical. There's a great quote by a comic singer named Tim Minchin where he says...

 

"“By definition, alternative medicine has either not been proved to work, or been proved not to work. Do you know what they call 'alternative medicine' that’s been proved to work? Medicine!"

 

Generally, I feel that if something works extremely well then it will become the standard treatment by default. Having said that, I've heard from a number of people who swear by Saw Palmetto but I have no plans to take it for hair loss.

 

gasto,

 

Thanks for the tip. I will certainly try it.

 

When I was in my teens and early twenties, I had some serious struggles with cystic acne and regularly visited a dermatologist. By the time I hit 30 it stopped completely and I had virtually no blemishes for probably about 12 years or so. Then, about 18 months ago I got hit hard. This was about 1.5 years after starting finasteride, a few weeks after starting Biotin and maybe starting a new multi-vitamin too. I immediately quit Biotin but the breakouts persisted. During that time I saw two dermatologists and my GP, took a variety of antibiotics and received intralesional injections with virtually no effect. Only recently has it finally come under control.

 

While all my docs stated that this was not due to finasteride, I feel that monkeying with my hormones just may have triggered something dormant in my system but don't know for sure.

[HARIRI]

Screw Propecia big time. A guy with a weak penis is killing more than a guy with little hair. Most of us trying to restore hair to be attracted by the opposite sex, whats the use if you can and then you wont be able to get it up when you want to. I just use Minoxidil and Saw palmetto 500 mg (better than nothing). For the love of God, everybody please stay away from Finasteride, it doesn't worth it. Sometimes when I was the bald truth show, it kills me when i hear Spencer Kobren defending Propecia all the time. I love this guy and his contributions in hair loss industry but I don't get his obsession on Finasteride although callers complaining about it.