Does finasteride causes birth defects to boys??

Thin

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I was told finasteride can cause birth defects. Is this true? Anyone had a child while on finasteride? Results?
 

VWdude

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only if a pregnant women is handling propecia or takes propecia orally... but other than that, no....

don't worry dude, get her knocked up and start a family of your own.
 

rapidfrontal

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I'll let you know Dec 4, 2005. My wife became pregnant about 6 weeks after I started taking Propecia.
 

Thin

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VWdude said:
only if a pregnant women is handling propecia or takes propecia orally... but other than that, no....

don't worry dude, get her knocked up and start a family of your own.

lol, I'll get on it :)


rapidfrontal said:
I'll let you know Dec 4, 2005. My wife became pregnant about 6 weeks after I started taking Propecia.

Please keep us updated.
 

rapidfrontal

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Thin said:
VWdude said:
only if a pregnant women is handling propecia or takes propecia orally... but other than that, no....

don't worry dude, get her knocked up and start a family of your own.

lol, I'll get on it :)


rapidfrontal said:
I'll let you know Dec 4, 2005. My wife became pregnant about 6 weeks after I started taking Propecia.

Please keep us updated.

I definitely will.
 

global

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They used to put a warning in the insert to wear a condom if your wife is pregnant as there is a VERY small risk the tiny quantity of Propecia in semen could cause feminization of male fetuses, but I think they've removed it now as the risk is so small as to be virtually non-existent.
 

Johnny24601

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re:

I hate to say it, but I am not going to knock up any lady when I am taking finasteride. If I start a family, it will be after taking a few months off of finasteride. I will lose my hair but I hope my priorities would be different, so I won't care.
 
G

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Is it really worth risking the genetic well-being of your kid for the sake of something as stupid as Propecia? Get off it for three months, then go to it. Otherwise, if something is wrong, you get to spend the rest of your life wondering whether it was Propecia's--and thus your--fault. Most people would rather lose an arm rather than have something be wrong with their kid, to say nothing of hair that was going anyway.

I actually can't believe anyone here wouldn't just consult a doctor, and I actually can't believe how many people ask this question. The bottle says for women NOT to touch broken capsule's, for crap's sake! Especially pregnant women! Put two and two together.
 

Bryan

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Alopecia-Nate said:
Is it really worth risking the genetic well-being of your kid for the sake of something as stupid as Propecia? Get off it for three months, then go to it.

THREE MONTHS??? Good god...

First of all, as Global pointed out, the FDA no longer even has any restriction on the use of finasteride by fathers-to-be. If _they_ think it's safe to use even during that entire period, what makes you guys so paranoid about it??

Second of all, three months is ridiculous. The drug will be gone from the blood serum in a couple of days or so after the last dose, and it's highly likely to have a similarly short lifetime in semen.

Bryan
 

rapidfrontal

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Alopecia-Nate said:
Is it really worth risking the genetic well-being of your kid for the sake of something as stupid as Propecia? Get off it for three months, then go to it. Otherwise, if something is wrong, you get to spend the rest of your life wondering whether it was Propecia's--and thus your--fault. Most people would rather lose an arm rather than have something be wrong with their kid, to say nothing of hair that was going anyway.

I actually can't believe anyone here wouldn't just consult a doctor, and I actually can't believe how many people ask this question. The bottle says for women NOT to touch broken capsule's, for crap's sake! Especially pregnant women! Put two and two together.


Well, I understand your point of view and you are kind of freaking me out, but before you continue making it seem so black and white let me say a couple of things in my defense of being the scumbag that made the conscious decision to risk the health of my child in order to save my hair.

First, if I was faced with that decision, of course, I wouldn't put my hair first. I choose to start taking Propecia because of the medical advice that I was given. I read that about pregnant women not handling Propecia and when I did I thought it most prudent to discuss it with those who know best.

My Derm is my Father and he and my urologist and my wife's OBGYN went to high school together at St. Louis University High School. My Father went to Georgetown for undergrad and Dartmouth for Medical School and they all three have been practicing here in St. Louis for about 30 years currently at St. John's Mercy Med Center which is highly respected. I discussed it with all 3 doctors individually plus my uncle who is also an OB(but not my wife's) at St. John's and they are all in agreement that there is no possibility of birth defects resulting from my use of Propecia. They have never seen or heard of it and they deal regularly with people who take it and try to get pregnant. They have all been involved in this 2 year long pregnancy process from the start. I am just giving all this information in an attempt to illustrate that my sources of medical advice are about as solid as it gets.

What this means to me is that the current school of thought in those 3 academies is that there is no fear of birth defects arising out of use of Propecia. This together with the fact that Merck says the same thing. Now I know there are a lot of people on HairLossTalk.com that are anti-big business/anti-capitalism/conspiracy theorists, but to me that just means that everything you hear on HairLossTalk.com should be taken with a grain of salt. Merck would rather one of their products fail than deal with multi billion dollar lawsuits for the next 10 years.

Now maybe I have made a big mistake here, we'll know in December, but given the medical advice under which I chose to take Propecia, I think most people would have agreed that it was okay. I still think so, as I am not a conspiracy theorist.
 

Cornholio

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RapidFrontal, as it is accepted on this site that physicians are all Big Parmacy w****s I bet your reasoning wont carry much weight with the more paranoid. Here is a little more data (doesnt always carry much weight here either :hairy: ) that shows why continuing finasteride is reasonable throughout pregnancy.

http://www.pharmcom.com/propecia_pharmacology.html

"Semen levels have been measured in 35 men taking finasteride 1 mg daily for 6 weeks. In 60% (21 of 35) of the samples, finasteride levels were undetectable. The mean finasteride level was 0.26 ng/mL and the highest level measured was 1.52 ng/mL. Using this highest semen level measured and assuming 100% absorption from a 5-mL ejaculate per day, human exposure through vaginal absorption would be up to 7.6 ng per day, which is 750 times lower than the exposure from the no-effect dose for developmental abnormalities in Rhesus monkeys"

That is with 5ml/day ejaculate... I may be alone on this but i have definately noticed decreased volumes with finasteride, meaning even on a good day 5ml is a kind and generous overistimate (meaning I guess I can't be a p**rn star)

Congratulations, and best of luck
 

Cassin

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You would have heard about it by now if it was a problem. The media would be all over it and MERK would be knee deep in class action hell.

And just so you know, I know two people who have had children while on Finatseride. Both had healthy baby boys, zero problems. All fingers and toes accounted for.

In fact, one celebrates his one year birthday this Saturday and there will be a huge BBQ feast to be had. Were going to have 3 BBQ grills going (charcoal only) I have no clue what to get a one year old.........
 

rapidfrontal

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Thanks, Cornholio. I agree with you about many thinking physicians are all big pharma w****s, and while I wouldn't take it that far, I have stated numerous times on HairLossTalk.com that Derms don't know sh*t about hairloss, including my Father. What I mean by that, however, is that most Derms really don't have a clue about things like treatments (outside of finasteride and minoxidil), shedding from finasteride, etc etc. For much about hairloss a place like HairLossTalk.com provides the best source of information. But when it comes to physiological sides from Propecia my Father and most Derms are knowledgeable because they prescribe it and when sides arise their patients talk about it. Shedding is not one that many Derms will pay much attention to because it is not a health concern in their eyes.

Cassin, I could not agree with you more. A lot of people seem to think that MERK doesn't put it in the product insert because it would kill the sales, but that is just plain dumb, because, like you said, they would be knee deep in class action hell. The bottom line is that if babies are suffering defects due to Propecia use, we would have heard of it by now. Instead, it is just a question people ask and will continue to ask forever or until birth defects start to develop. As far as a Bday present for a 1 year old, I wish I could help, but seeing as I don't have any kids, yet, I am totally clueless about them. I am due for a very rude awakening in December.
 
G

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I'm glad to hear you've consulted several doctors, that was a good idea. And I'm also glad to hear that all studies so far indicate propecia isn't dangerous for pregnant women and their children. And Bryan says that it's out of your blood stream in a matter of days (I'd check with your dad on that one--I don't believe Bryan is a doctor, unless I'm wrong about that, too).

Here's what no one can tell you: how healthy a ten year-old child whose father used propecia. Why? Because finasteride--as a hairloss drug--has only been in use for seven years. Which means not only do you not know how healthy a ten year old kid would be, you don't know how healthy a nine year-old kid would be, etc. Furthermore, it's a little tiring to hear people quote Merck. For christ's sake, people, this doggerel about "paranoid" "anti-corporate" posts is not timely. Take five seconds to do a google search and you'll find at least THREE big pharma companies in the PAST YEAR who have had to remove products from the market due to their helping KILL people. Merck will happily put a drug on the market that will do big-time damage, as long as the potential lawsuits don't outweigh the benefits of selling the drug until those lawsuits come, or the costs of the lawsuits themselves. Didn't anyone watch "Fight Club"? It's a simple cost/benefit analysis.

Anyone who still puts faith in the FDA, to say nothing of Merck, simply isn't reading his family newspaper.

Anyway, it sounds like you'll make a very educated decision whatever you do, I just wanted to make sure I provided a better-rounded discussion to this thread. You must keep in mind everyone here (the moderators, anyway) thinks Propecia is a godsend. Fact is, no one knows what this godsend has in store in the next ten years, since no one's been using it for hairloss for more than seven.
 

Cornholio

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There is no reason to suspect that abnormalities will appear in older children of propecia users as they made it past the much more sensitive gestational period without changes, they had minimal to no exposure to the drug (as above) and, had they carried the drug with them it would be long gone. Come puberty they will make their own testosterone which will be converted to DHT and cause their hair to fall out... Hope there is a better treatment for them. But, as you said, we will see this in a few years.

The recent withdrawl of major drugs is a good illustration of how drugs are approved, and how even released drugs are under surveilance. Phase I trials look for gross toxicity, Phase II look roughly at efficacy and toxicity, Phase III look at more people and will pick up more subtle effects. Then, after a drug is released to the public millions may take a drug. Suspected adverse events are reported by physicians and this information is tracked. If the effect is subtle it may take decades for the adverse events to be noted (for example, estrogen replacement in women). If the event is unexpected or subtle the initial suspicion may initially seem to be explained by other confounding variables.... That is, until a persuasive study makes the danger clear (as with hormone replacement or Cox II's). At that point a company may withdraw a drug because the cost is greater than the benefit, or make the product warning clear about the new understanding of risk (as will probably be done with Vioxx, as it will likely remain available with a warning).

Regarding Cox II inhibitors like Vioxx, the initial rumblings about possible increased cardiac events seemed to be explained by the fact that Cox II inhibitors lack the cardioprotective effects of aspirin... This was the line used by drug reps with physicians and seemed reasonable. When followup studies showed that the Cox II inhibitors increased cardiac events independantly the drug was pulled. The critical question (which will make or break the vioxx liability trials) is whether the gathered data was reported and responded to in a timely manner by the pharmaceutical co's. The last 1 year or so before withdrawl will be looked at closely. No one is suggesting that pharmaceutical companys are perfectly altruistic. On the other hand the product insert and black box warnings are their best defense, and if their lawyers are aware of a miniscule possibility of an adverse reaction it will be on that insert for legal defense reasons. The fact that vioxx didn't have and propecia doesn't have that black box warning is remarkable and does say something about their confidence.

By taking any medication you agree to be part of the larger post-marketing experiment that goes on with all drugs. In taking a medicine your risks have been reduced (and quantified on the product insert) as much as possible,... To have zero risk take no medication, however you will still die eventually :wink: )
 
G

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Cornholio said:
The recent withdrawl of major drugs is a good illustration of how drugs are approved, and how even released drugs are under surveilance.

Dude, those drugs WEREN'T under surveilance. The New York Times reported recently how the FDA's funding toward post-market drug testing and surveilance is all but nonexistent. The reason they were pulled was because too many people were dying and having strokes caused by them, and the lawsuits finally started making the cover page. That's not surveilance. And no, big pharma isn't only perfectly altruistic: if anything it's misanthropic, to the degree that studies in the trial phase of Vioxx showed that strokes were possible--even probable. Merck scientists were evil enough to suppress these studies; the FDA was evil enough in their complicity to allow the suppression.

The fact that you're mentioning Vioxx and Propecia in the same phrase in an attempt to bolster our confidence in Propecia is a very strange way of supporting your argument.
 

Cornholio

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"The fact that you're mentioning Vioxx and Propecia in the same phrase in an attempt to bolster our confidence in Propecia is a very strange way of supporting your argument."

Everybody has to decide for themselves whether they are comfortable or not with propecia. I mentioned vioxx because you made the reference to the withdrawl of major medications recently, and I was expanding on that point (as you were discussing Vioxx without naming it). It is useful for others to know how medications are approved and later monitored (and post-marketing surveilance is used). It is inevitable that at the completion of phase III trials some drugs are approved with side-effects that only greater use will reveal.

To say that there is no monitoring or mechanism that allows adverse events to be monitored is incorrect. The behind the scenes discussion and "who knew what when" will be key in this episode... T

.........The initial Vigor trial from 2000 was a single relatively small trial (8000) which raised questions of vioxx safety. Others of the same time showed it was safe. "One possibility was that it was the result of chance. Another was that the problems were caused by Vioxx. And the third was that naproxen provided heart protection and had skewed the results. Merck researchers looked for data from other studies, aware that studies of two other little-used painkillers in the same class as naproxen had shown cardioprotective effects.

In the spring of 2000, Merck researchers also reviewed safety data from a continuing study in which Vioxx was being used in patients with Alzheimer's disease to test a theory that the painkiller might slow the disease's progress. Dr. Reicin said that there was no evidence in that study, which had started in 1998, that Vioxx posed a risk.

Merck researchers soon concluded that naproxen was cardioprotective. Some academic researchers, including some who consulted for Merck, also supported this theory."

The agency hired a cardiologist to take a careful look at the studies, and it summoned a panel of independent experts to discuss the data publicly.
The panel met in February 2001, and while several members expressed concerns about the heart risks, none suggested that the drug be withdrawn. Doctors on the panel who treated ulcers argued that Vioxx's protective effects far outweighed its possible harm to the heart; cardiologists argued that the drug's possible harm to the heart was a real problem. All agreed that more studies should be done.

In early 2000, the company had started a clinical trial to determine whether Vioxx could prevent the recurrence of colon polyps. Merck decided to intensely monitor the cardiovascular condition of patients in that test, known as the Approve trial, as well as subsequent studies. Dr. Reicin said last week that she and others at Merck felt devastated when they learned this past September (9/04) about the findings from the colon polyp trial. But she said she believed that running the trials as the company did was the best way to learn whether the drug had a problem or not.

"We did our best to think of the most comprehensive study we could have done," she said. "I'm sorry that I didn't know four years ago what I know now, but the data didn't lead us there four years ago." ......................."

There was surveilance and discussion since the release of vioxx in 1999. There was suspicion but not the kind of evidence needed for withdrawl in 2000. With the evidence obtained in summer 2004 it was withdrawn. The Vigor study was not supressed, it was available and debated. No advisory panel was calling for the withdrawl of the drug in 2000. The next data was in 2004. The study of 8000 (vigor) was not designed to look at cardiac death, could not answer the "why" of this unexpected result, and could not disprove that naprosyn in the control group (or random events) did not explain it.

I will agree that drug reps should have marketed it with this known question more loudly stated, but up to 2004 it was only that... A question and suspicion. The FDA and Merk did discuss whether a new study would help, and studies currently underway were chosen. A free, aggressive FDA might have pulled the drug based on an arthritis study of 8000, but it is hard to know if it would have given what they knew then (other benign studies)...

I do agree that the FDA should have a freer hand in approving drugs and removing drugs from the market when needed... However as it is now it takes years and an expected 500million dollar annual income for companies to even try to bring a new drug to market. This is the reason that I do not expect any innovative FDA approved alopecia drugs in the future (we're cheap :D ). A "safer" system is also a slower less responsive system.

I say this all to illustrate my view that physicians and the pharmacies arent Evil but rather involved in a complicated process...

I dont think that there are any legitimate hints that propecia has serious irreversible side-effects (beyond the occasional breast) but if your confidence in the production, development and approval process is so marginal you probably shouldnt take any perscription medication. It is always a risk/benefit choice, and with your predisposition you cant be comfortable with the risks.
 

Johnny24601

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re:

The reality is that finasteride use and its long term effects (10, 20, 30 years) down the line has not been fully analyzed for either the finasteride user or his off spring. Deep down I feel like the potential for negative effects on a fetus are extremely rare. The reality for me is that my hair is not that important to the point where I would risk anything. This could be an overly paranoid approach as diet, exposure to air or water pollutants, physical health and millions of other factors could adversly effect semen quality and thus the fetus so where does one stop at?
I don't look down on you for continuing the medication, I just was putting in my opinion and wish you the best of luck. At this point I think it is important for you to not dwell on your decision as that would cause useless stress and anxiety and that is the last thing you, your wife and your developing child needs right now.
Merck, the FDA, doctors and the opinions of everyone on this website MUST be taken with a grain of salt. As in everything in life, we must all take in what everyone has to say and form our own opinion
 

rapidfrontal

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Well, I appreciate everyone's input and I find all this very interesting, but it is hard for me to be overly concerned about 10+ years down the road. We deal with this aspect with every new drug, prescription and otherwise that comes down the pipeline. Now when my child is involved, I agree it adds a bit more to the mix to be concerned about. I don't agree about the above evilness of the scientists. That is simply not the case. Nor is it the case with the cost/benefit analysis. Sure cost/benefit analysis is a real part of many businesses, but let's not going around supporting this arguement by referencing Fight Club. I did see that movie and, besides the fact that I hated it, it is Hollywood and therefore eliminated as anything that has any credibility. That being said, there are some interesting points of view on both sides stated here and I am happy to be hearing other people's input.
 
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