Propecia Problems: Baldness Drug Linked with Long-Lasting Sexual Side Effects

The adverse side effects of the anti-baldness drug could last for months or even years for some men

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In April, the Food and Drug Administration (FDA) updated the warning to finasteride, Merck & Co.’s drug marketed to treat both male pattern baldness (Propecia) and enlarged prostate (Proscar). The new warnings noted that the sexual side effects associated with the medication, including problems with libido, ejaculations and orgasm, could last even after patients stop taking the drug.

Now a new study published in the Journal of Sexual Medicine finds that side effects may not only continue after stopping finasteride, but they may last for months or even years.

In the study, Dr. Michael Irwig of George Washington University and his colleagues surveyed 54 men under age 40 who reported experiencing side effects for three months or more after stopping the medication Propecia. The patients reported a variety of sexual problems including erectile dysfunction, low libido, trouble having an orgasm, and shrinking and painful genitals. Some men also reported neurological problems like depression, anxiety and cognitive haziness.

For 96% of the men, the sexual problems lasted more than a year after they quit using the drug. None of the men had sexual, medical or psychiatric complaints before taking Propecia.

(MORE: Could the ‘Cuddle Chemical’ Oxytocin Improve Male Sexual Function?)

The study sample was small and the authors acknowledge that it may be skewed to include only men who were most negatively impacted by the drug. Most of the participants were recruited through an Internet forum called Propeciahelp.com, for men experiencing persistent side effects.

Still, the authors argue their findings may signal potentially serious risks for men using finasteride. “Our findings make me suspicious that this drug may have done permanent damage to these men,” Irwig told ABC News.

The FDA’s updated warning labels for finasteride were based on a review of post-marketing reports of sexual dysfunction. The agency reviewed 421 post-marketing reports of sexual side effects related to Propecia from 1998 to 2011; out of these cases, 59 reported adverse sexual effects lasting over three months after discontinuing the drug. For Proscar, the FDA reviewed 131 cases of erectile dysfunction and 68 cases of decreased libido from 1992 to 2010. As Healthland reported in April:

Finasteride labels will now warn users that Propecia’s side effects can include libido disorders, ejaculation disorders, and orgasm disorders that continue after discontinuation of the drug and that Proscar can lead to decreased libido that continues after quitting the drug. Both medications will receive a new description of reports of male infertility and poor semen quality that normalized or improved after stopping therapy.

“Despite the fact that clear causal links between finasteride (Propecia and Proscar) and sexual adverse events have not been established, the cases suggest a broader range of adverse effects than previously reported in patients taking these drugs,” the FDA said in a statement.

(MORE: Study Finds Pattern in Male Baldness: Could There Be a Cure?)

Irwig acknowledges that the number of men experiencing long-lasting side effects from finasteride is small, although the incidence of sexual side effects in clinical trials was around 2%, the incidence of persistent sexual side effects is unknown, but likely less than 0.1%. “But because the medication is prescribed so commonly, it’s still a lot of people, likely several thousand men around the world,” Irwig told ABC News.

Both the FDA and Merck maintain that finasteride is safe and effective.

19 comments
HairMax LaserComb
HairMax LaserComb

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Phillip Jennings
Phillip Jennings

The real issue here is this: Why is it that when BP's oil rig spews

millions of gallons of crude into the Gulf of Mexico, the company knows

it has no choice but to react responsibly and compassionately toward

those living in the area whose homes and livelihoods have been

decimated--namely by cleaning up its mess and allocating billions of

dollars to repairing the local economy. And yet, when Merck causes

damage of equal scope to men the world over, the company is allowed to

throw up an iron fence and say, "The victims have no proof that a crime

has been committed. But if they insist on complaining, talk to the FDA

-- and their doctors." After considering this, is there anyone on earth

who has an ounce of respect for Merck CEO Ken Frazier? I for one

cannot understand how his own wife and children inhabit the same home

with such a sociopath. Personally, I'd chop off his manhood, toss it

into the Gulf of Mexico, and when he cried for help, tell him to log

onto the FDA's website and report his boo-boo.

Jeffrey Klein
Jeffrey Klein

Propecia was marketed by the manufacturer, Merck, as a “miracle pill”

for men with hair loss.  However,

this “miracle” had some undisclosed strings attached in the form of harmful sexual,

neurological, and hormonal side effects. 

Despite receiving adverse reports almost immediately after its

introduction to the market in 1997, Merck refused to add any additional

warnings until the FDA ordered Merck in April of 2012.  New cases are being filed against Merck

to seek claims for damages as more men come forward to report their negative

side effects.  PropeciaLawyers.com is

a vital resource for men affected by Propecia side effects, because it offers

the latest in Propecia News and informational Propecia Videos. To stay up-to-date

on the most recent Propecia related news, visit www.propecialawyers.com and

click on our Propecia News page to get in-depth news regarding Propecia side

effects and Propecia lawsuits. 

Jonathan_abc
Jonathan_abc

It is so widely reported that 90+% people in this study experienced the side effects, yet this part is usually missed:  "Most of the participants were recruited through an Internet forum called Propeciahelp.com, for men experiencing persistent side effects."  Plus, with no control group, there's no way to tell how many of them would have had these problems anyway.  Someone should do a real study on this instead of misrepresenting this preliminary study.

Bojorco
Bojorco

So I should take this stuff to keep my hair so I'll be more attractive to the babes...but then my libido will grind to a halt and I won't even care anymore?

need2banon
need2banon

The symptoms described for this condition are precisely what I have experienced, undiagnosed over the past several years.  I have been using this "FDA approved" drug for over 10 years now and I am a classic case of the sexual dysfunction symptoms related to this condition.

This is very serious to me because I have attributed these problems to low testosterone and other  possible conditions for which I did not test positive.

I would encourage anyone who is a stakeholder in this this study to take its finding very seriously.  There is a great deal of truth to be found here, and unfortunately, given predicament, I believe that there is much more evidence to be uncovered.

Merck is a very large and powerful pharmaceutical company having all of the lobbyists and public relations people on staff to try and squash this type of discovery.   I hope that honest and ethical people who come across the truth regarding these unfortunate side-effects of Propecia have the courage to protect people from who are considering taking this drug.

For people such as myself, I hope that the truth regarding our fate and what we can expect in terms of recovery will be openly and honestly communicated.

need2banon
need2banon

The symptoms described for this condition are precisely what I have experienced, undiagnosed over the past several years.  I have been using this "FDA approved" drug for over 10 years now and I am a classic case of the sexual dysfunction symptoms related to this condition.

This is very serious to me because I have attributed these problems to low testosterone and other  possible conditions for which I did not test positive.

I would encourage anyone who is a stakeholder in this this study to take its finding very seriously.  There is a great deal of truth to be found here, and unfortunately, given predicament, I believe that there is much more evidence to be uncovered.

Merck is a very large and powerful pharmaceutical company having all of the lobbyists and public relations people on staff to try and squash this type of discovery.   I hope that honest and ethical people who come across the truth regarding these unfortunate side-effects of Propecia have the courage to protect people from who are considering taking this drug.

For people such as myself, I hope that the truth regarding our fate and what we can expect in terms of recovery will be openly and honestly communicated.

mdphd05
mdphd05

Any clinical data collected from a specific sub-group (in this case, 71 younger men (age 21-46) who experienced lasting sexual side effects at least three months after stop of treatment) should not be used to draw a conclusion for a general population as what NBC Nightly News tried to do last night. This particular research admits its limitations including selection bias.  Being a dermatologist, I know first hand how prevalent this drug is used in treating male pattern baldness (one of the only two medicines proved by FDA to treat this disease). All of my patients were told of potential side effects (including  teratogenic effects--causing abnormalities of male sexual organs in babies-- that is why it's an absolute contraindication for couples who are trying to have babies or are sexually active without using birth control of any forms), as outlined in the results of Merck's clinical trials. The toxicities of taking 1mg finasteride (Propecia) per day were within the acceptable standards by FDA, thus Merck received the green light for marketing it as a male pattern baldness medicine in 1997 in addition to the higher dose Proscar for benign prostate enlargement in older men.  

For those patients (~2%) experiencing long term sexual function decline, that is a very real and devastating side effect, but we should not jump to the conclusion and demand the drug being removed from the market (as some news media apparently are doing). Many drugs have higher rates of causing toxicities or side effects, including blood pressure medicines, blood sugar controls, pain killers and cancer chemotherapy agents. Weighing the pros and cons of taking any medicine is always a delicate decision that has to be made together by doctors and patients. 

This research published by GW last year meant to discuss an issue that is real to a special group of patients, and to raise awareness among physicians and patients of the potential dangers. It DOES NOT mean to imply 94% men who take the medicine would end up losing their libido, becoming impotent and having female pattern breasts (gynecomastia). 

Han Sooloo
Han Sooloo

 haha.  you may be a dermatologist, but your rationality is questionable. 

You stated, "Many drugs have higher rates of causing toxicities or side effects,

including blood pressure medicines, blood sugar controls, pain killers

and cancer chemotherapy agents. Weighing the pros and cons of taking any

medicine is always a delicate decision that has to be made together by

doctors and patients. "

The drugs you listed with higher "side effects" and "toxicities" are drugs used to sustain or restore life.  "cancer chemotherapy agents", "blood pressure medicines" all will allow you (hopefully) to live longer.   So clearly the reward outweighs the risk when it comes to maintaining life.  Propecia does not sustain life or make life more "live-able".  If the patient is suffering from depression as a result of male pattern baldness they should be prescribed an anti-depressive.

presetsbranch
presetsbranch

Again, these are issues that should be addressed at the outset of therapy-- that is, is the risk of these side effects worth taking the drug for your hair loss? That is a decision that the patient needs to be making along with the physician, it is ultimately the patient's choice to accept the safety risks which are well-documented in the evidence. You acknowledge the idea that no one needs to be on finasteride for androgenic alopecia as it does not really have any mortality reduction associated with it for this indication. So is the risk worth it (even acute effects)? Also bear in mind that the majority of antidepressants are associated with sexual dysfunction as well. I know you will say that the long-term risks were not known at the time when the drug was prescribed to many patients and Merck was trying to cover it up-- but the long-term information was simply not there at the time. When approved, the FDA saw that the risks were acceptable in the face of the benefits (both in androgenic alopecia and BPH). As with any new drug, post-marketing surveillance monitors the safety of an agent down the road. Clinicians do the best they can with the current evidence. 

In response to your idea of long-term clinical trials to look at safety of finasteride: that is what post-marketing surveillance is for my friend and it takes time to amass data regarding long-term safety obviously-- that is why it is only coming out now. You are more likely to see observational studies addressing the long-term safety risks as opposed to long-term clinical trials. Pulling the drug from the market now is a bit severe as these side effects are experienced in a very low number of patients and they are not life-threatening (albeit serious). Typically, when you see a drug pulled from the market it will be due to much more serious concerns as lactic acidosis (eg. phenformin) or cardiovascular complications (eg. rofecoxib, sibutramine). Remember that finasteride and dutasteride are also used in BPH and have well-documented efficacy-- they indeed make these patients' lives more liveable. Pulling the drug off the market would also affect this subset of patients.

Billteud
Billteud

Wait, what?  You interviewed *only* people from a web forum for hypochondriacs who think that the drug caused them problems?  That is so utterly unscientific.

The plural of anecdote is not data.  Correlation does not equal causation.

I've been taking a knock-off of this stuff for 6 years and I have absolutely no problems.  It definitely works, too.

Leelo4
Leelo4

Before you blast everyone I would like to tell you my personal experience.  My husband took Propecia for 15 years.  Had we known the side effects he would suffer he would have NEVER taken it!  He is NOT a hypochondriac! We are both hard working, well educated people. We had no idea what was causing the "brain fog" and other horrible side effects.  We have read others stories and they read EXACTLY like our life.  I am glad that you did not suffer side effects..not all do...but a word of caution..it took 10 years before my husband had any side effects so be careful who you judge! You should have some sympathy for the people in there 20's whose lives are now ruined because they will never be able to have a normal relationship with a woman.  Shame on you!

ACH369
ACH369

Bill, you are amazing...a web forum for hypochondriacs???!!!  How dare you!!!  You have no clue whatsoever as to what is really going on here...you are just LUCKY!!!   To call anyone a hypochondriac who is going through the absolute horrors of this drug is so cruel...think before you speak, Bill...and count your blessings...this could easily have befallen you and you would have been singing a much different tune!

 

presetsbranch
presetsbranch

ACH369, I am talking about clinical studies involving finasteride and the body of literature as a whole, not Merck or your particular physician. I am responding to the actual study in question here not with your particular case. I am sorry that your husband's practitioner was not up front with you but again, my issue is more with disseminating information that does not represent the experience the typical patient will have with this drug. Of course it is important that the public is aware of the possible serious side effects but it must be realized that the risk exists, it doesn't mean that this is going to happen to every single patient who takes the drug. I am not here to argue with you about Merck but the evidence.

Han Sooloo
Han Sooloo

 "The literature shows that there is a clear risk these side effects can occur-- nothing is being covered up here."

The clinical trials lasted 5 years.  Those clinical trials resulted in no lasting problems.  Now that people are taking the drug longer than 5+ years the drug is rearing it's ugly head by showing some nasty long lasting side effects.   The FDA needs to perform a longer clinical trial and publish those results, and in the meantime pull the drug from the market.

presetsbranch
presetsbranch

 I sympathize with your husband's situation but my point is that this is the risk that is accepted when taking finasteride. The literature shows that there is a clear risk these side effects can occur-- nothing is being covered up here. The data is out there, the sexual side effects are acknowledged. I simply wanted to speak to the fact that this study does not reflect the majority of patients who will see benefit with the drug and feel that this outweighs side effects. I am not arguing that long term side effects may be a reality but are the rates so high that it should deter patients from taking the drug? That remains to be seen, I do not believe this study offers the answer though. Of course there are the small number of patients who will not be able to tolerate it but again it all comes down to the fact that in most patients the benefits will outweigh the harm. I cannot speak to Merck's position on this but only what is shown in the literature. As I mentioned previously, given the risks of this therapy it is important to communicate to patients the possible side effects prior to initiating and taper a plan accordingly. As a patient, is the risk of sexual side effects something which you are willing to accept given the possible benefits of the drug?

ACH369
ACH369

You say your point is "that this is the risk that is accepted when taking finasteride", and that "the literature shows that there is a clear risk these side effects can occur...nothing is covered up here"...please read over my post again...IT ABSOLUTELY WAS COVERED UP, that's what I've been saying!  

I think for any drug, as long as the patient is told up front what might happen, then the patient can make a choice as to whether or not they want to take the risk...THIS WAS NOT THE CASE WHEN MY HUSBAND WAS PRESCRIBED FINASTERIDE...he was lied to...had he been told the truth, he would never, ever have taken the drug and all would still be well in our world!

Do you see what I'm saying?

presetsbranch
presetsbranch

You have to acknowledge the selection bias in this study though--the conclusions are hardly surprising considering the way subjects were recruited. It is not a very good representation of the average patient who is taking this drug. I am not making light of the unfortunate sexual side effects of finasteride and dutasteride but they are certainly widely acknowledged and in starting either of these drugs you hope that the benefit will outweigh the possible side effects. It is something that any responsible practitioner should communicate to patients before initiating these drugs.

ACH369
ACH369

I understand what you're saying...my absolute objection to the comment had to do with the completely cruel remark 'a web forum for hypochondriacs'...that was a horrible thing to say.  The forum started because men were becoming morphed human beings from this drug and they didn't know what was happening...so they googled their symptoms and ended up at PropeciaHelp.com...it's a devastating read, let me tell you.

Merck, the FDA and Bosley all lied about finasteride, and that is the absolute bottom line...there are people at Bosley who were still saying, even after the facts became known in the US, that it was a safe drug to take and if you did have sexual side effects they would go away after you stopped taking it...I HAVE PROOF.  Larry Bosley himself said some years ago it was a dangerous drug and should never be prescribed...he then created his own finasteride dispensary!Merck knew what this drug could do and they let people in Europe know about it...but not in the US...what help did the FDA give anyone?  NONE!!!    Don't forget that Merck was the devil behind the thousands of deaths from Vioxx.If I sound bitter, I guess I am...my husband is only 25 years old...our sexual life is non-existent...more than likely we will never have a family...he can't work because his brain doesn't function as it used to...he goes in and out of a mental fog that literally renders him useless for any type of work...he hardly sleeps...his skin has even changed.  Is he depressed?   Absolutely!  Am I depressed?  Absolutely!  But when I see an ignorant comment like the one that was mad about  'hypochondriacs', it makes me so angry I could spit nails...Kind of makes me wonder if he was one of Merck's people...they've been putting comments out there to try and make this seem like no big deal...IT'S A HUGE DEAL...Anyway, thank you for your comment...