Finasteride Questions

[jagdish]

The following CAUTION is written on Finax Cover.

 

<span class="ev_code_RED">CAUTION: Crushed or broken tablets should not be handled by women who are or may become pregnant. In addition, since it is present in semen, male patients should wear a condom or otherwise avoid exposure of female sexual partners at risk of becoming pregnant.</span>

 

What side effects will she get if a pregnant woman is effected by Finasteride? Birth defects or miscarriage?

Does that mean I should stop taking Finax while trying to conceive? What happens if I stop finax for a month or 2 and restart. Will it work as usual or I will stop responding to it?

[pokerbrat]

From what i understand, it most likely will cause birth defects. You should stop taking it if you are trying to conceive. If you stop for a month or two and restart it still will work although you may lose the hair you have been holding on to. Hope that helps!

[NervousNelly]

Jagdish,

 

If you are trying to conceive please stop taking. Yes it could affect the fetus as well as your wife.

 

It won't be a big deal at all if you stop for a few months. Besides my friend, you have plenty of new grafts! They are going to grow and you'll have hair irrigardless of any medications.

 

Take care.

 

NN

[jagdish]

pokerbrat, NN, Thanks for the info.

I will stop taking Finasteride. My hairloss was real fast before I started Finax. I am now worried that I may loose hair with the same speed again. New grafts are there but I am worried about the area behind the new grafts. Anyway I am not going to take any risk. Thanks again for the advise.

[Bill - Seemiller]

From what i understand, it most likely will cause birth defects. You should stop taking it if you are trying to conceive. If you stop for a month or two and restart it still will work although you may lose the hair you have been holding on to. Hope that helps!

 

 

I have talked to a few hair transplant doctors about this (includin Dr. Hasson) and they have refuted the above statement.

 

Jagdish,

 

I have read the first part of the caution statement a hundred times but not once did I EVER see the second part. Can you point me to where you are getting this information?

 

Thanks,

 

Bill

[Bill - Seemiller]

This was copied right from Propecia's website.

 

The URL can be found here: http://www.propecia.com/finasteride/propecia/consumer/p...de_effects/index.jsp

 

"Women who are or may potentially be pregnant must not use PROPECIA and should not handle crushed or broken PROPECIA tablets because the active ingredient may cause abnormalities of a male baby's sex organs. If a woman who is pregnant comes into contact with the active ingredient in PROPECIA, a doctor should be consulted. PROPECIA tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed."

 

Now notice the next statement:

 

"Contact with the semen from a man being treated with PROPECIA is not a risk to the unborn child of a pregnant woman."

 

Bill

[NervousNelly]

I guess I stand corrected. I guess?? I thought the same as what Jagdish posted. I wonder why the discrepency?

 

 

NN

[Bill - Seemiller]

I don't know...but it appears if you look up on google the second half of his sentence, information can be found. If anyone wants to do some leg work on this - that would be great. Otherwise, I'll get to this over the next week or so! Inquiring minds want to know the truth.

 

Bill

[jagdish]

Bill,

The caution in my first post is copied from Finax box that I purchase once in every 50 days. Finax is generic propecia containing finasteride 1mg manifactured by Dr.Reddys Labs. Propecia is not available in India. Finax has been working well for me without any side effects.

Now I got a new question. Is Finax is different from Propecia in case of trying to conceive? Propecia does not cause the finasteride to be present in semen and Finax will cause to be present? I am more concerned because this caution is present on the Finax box itself. I don't remember seeing this kind of warning on Finpecia box which is another generic propecia available in India.

I know it is difficult to get a definitive answers to these questions. I think it is better to be safe than sorry. No Finax for some months. I miss you Finax.

[pokerbrat]

Bill- what part of my statement wasn't true? Fin does cause birth defects..you cant try and conceive while on it. My doc said if you are on fin and are going to try and have a baby you should get off it for a while, then go back on it. Is that the part that was wrong..if not, please let me know since i am on fin and i would like to know if i am mistaken...thanks

[Guest]

If you don't know, Don't take chances.

 

Just my opininon.

[Bill - Seemiller]

All I can tell you gentlemen from a non-medical perspective is that Propecia's website states

 

"Contact with the semen from a man being treated with PROPECIA is not a risk to the unborn child of a pregnant woman."

 

The statement above that does warn that a pregnant woman should not HANDLE broken tablets - which does indicate the potential for birth defects. I ASSUME (though I know this is dangerous) that this could only happen if a woman injests some of the medication.

 

But the red text above clearly states that an unborn child is not a risk from a woman being in contact with semen from a man who is being treated.

 

Why the difference between finax and propecia? I couldn't tell you! It makes me wonder if there is something different in finax than propecia. Or perhaps they were trying to copy Propecia's warnings but they got it wrong. I don't know.

 

But it's worth finding out! Perhaps a doctor can intervene.

 

Bill

[Dr. William Reed]

This is not an easy question to be comfortable with in view of how delicate fetal development is and how we don't know what we don't know until we know that we didn't know it.... That said, however, a reassuring argument based upon what seems sound reason and good data can be put forward (so that if a woman were impregnated by someone using finasteride, he and she can feel comfortable with their situation because of the data):

 

Regarding female exposure: A woman can, but need not be, exposed via the dust of a quartered pill of a 5mg tablet of finasteride. I quarter my 5mg tablet by biting it and am comfortable that no powder is released to create an exposure problem. If one were not comfortable with that, then they should use the 1 mg tablet. Quoting the PDR: "PROPECIA tablets [i.e. the 1mg tablet] are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed." I believe that to be true.

 

So if the woman were not exposed by powder the other way is via semen. This, too, has understandably been well studied. Again found in the PDR are the following studies: "Semen levels have been measured in 35 men taking finasteride 1 mg/day for 6 weeks. In 60% (21 of 35) of the samples, finasteride levels were undetectable (<0.2 ng/mL). The mean finasteride level was 0.26 ng/mL and the highest level measured was 1.52 ng/mL. Using the 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 and 650-fold less than the dose of finasteride (5 mug) that had no effect on circulating DHT levels in men."

 

These data are quite reassuring, yet we don't know what we don't know.... That's why I recommend stopping finasteride during pregnancy or using condoms. This recommendation is probably treating the psychological rather than the physiological, but that's okay.

 

The whole situation spins off from the male fetus at weeks 12 to 15 needing the miniscule difference of androgen that he has compared to a sister fetus because it is then that his genitalia become "male". That's where DHT comes in to exaggerate this small difference of testosterone that the male has since DHT is perhaps five times more powerful than ordinary testosterone. This amplification from DHT makes his male genitalia more a "black and white" result rather than some shade of grey. Five alpha reductase (which is blocked by finasteride)is the enzyme that creates the DHT from testosterone. Pretty amazing, even going beyond the miraculous, don't you agree?

 

So in conclusion, in my best medical opinion, I wouldn't worry about birth defects with finasteride if care is taken to prevent exposure to the female throughout her pregnancy and if care is taken to identify pregnancy in the first several weeks. Of course in today's world I have to throw in the usual disclaimers that without talking personally to a patient I can't take into account each person's potentially unique circumstances and can't offer specific medical advice to the individual, etc.

 

I hope you find this useful.

 

Best regards,

[Bill - Seemiller]

Dr. Reed,

 

I appreciate your insight into this matter.

 

It appears from the data you've presented that there should be no physiological concern of a women who is pregnant coming into contact with semen of a man being treated with finasteride. This is evidenced in the statement above on Propecia's website.

 

Though I certainly can understand a level of pre-caution - after all, we are talking about a human life here and certainly want to ensure the child's safety at all costs.

 

If you don't mind, I'd like to use your post as a Hair Loss Q&A Blog posted at www.regrowhair.com. I will also send you a private message.

 

Thanks for your insight,

 

Bill

[magalh????es]

FINASTERIDE AND BIRTH DEFECTS

 

There are very few more anxiety provoking times in anyone's life than possibly causing a birth defect in one's own unborn child. So, it's quite understandable that the mention of a possible birth defect with the use of finasteride (Propecia 1mg and Proscar 5mg, Merck) would cause considerable anxiety and concern. The package insert for Proscar states under the section on Contraindications: "Because of the ability of Type II 5alpha reductase inhibitors to inhibit the conversion of testosterone to DHT, finasteride may cause abnormalities of the external genitalia of a male fetus of a pregnant woman who receives finasteride". So, is the risk real? Theoretically, yes. Practically, no.

 

The specific birth defect that can be caused by the absence or inhibition of the Type II 5-alpha reductase enzyme in the male embryo is hypospadias. Hypospadias is a birth defect in which the urinary tract opening is on the ventral surface (under side) of the penis rather than at the tip of the penis. There have never been congenital abnormalities observed in female fetuses at any dosage of finasteride.

 

During the research and development phase of finasteride, studies were done on experimental animals. Rats, rabbits, and rhesus monkeys were given finasteride to determine its relationship to birth defects, i.e. hypospadias.

 

Hypospadias did occur in the male offspring, when pregnant rats were administered finasteride equivalent to 5-5000 times the amount of recommended for men in treating MPB (1mg/daily). The critical period during which these effects can be induced in male rats was determined to be during the 16th ??“17th days of gestation.

 

In rabbit fetuses exposed to finasteride in utero from days 6-18 of gestation at doses equivalent to 5000 times the recommended human dosage, no evidence of malformations was observed. This result would be expected, since there was no exposure during the critical period of genital system development in rabbits.

 

When pregnant rhesus monkeys were given intravenous finasteride at a level equivalent to at least 750 times the highest estimated exposure of pregnant women to finasteride from semen of men taking 1mg/day, there were no genital abnormalities observed.

 

In the human embryo, the sensitive period of external genitalia development is during the 7th - 9th weeks of gestation. Although the chromosomal and genetic sex of an embryo is determined at fertilization by the kind of sperm, either Y-bearing or X-bearing, that fertilizes the ovum, male and female morphological characteristics do not begin to develop until the seventh week. Prior to this time, the genital systems of the two sexes are similar, and the initial period of genital development is referred to as the ??indifferent state of sexual development'. About six weeks after conception, if a Y chromosome is present in the embryo's cells (as it is in normal males), a gene on the chromosome directs the undifferentiated gonads to become testes. If the Y chromosome is not present (as in normal females), the undifferentiated gonads will become ovaries. If the gonads become testes, they begin to produce androgens, primarily testosterone, by about eight weeks after conception. These androgens stimulate development of the one set of the genital ducts into the epididymes, vas deferens, and ejaculatory duct. The presence of androgens also stimulates development of the penis and the scrotum. Hypospadias can result if there is inadequate production of androgens by the fetal testes.

 

Since the sensitive period of development of the external genitalia in the human embryo is the 7th to 9th weeks of gestation, there can be no danger to the child if the father is taking finasteride at the time of conception. Originally, Merck decided to err on the side of caution and warned against the possible problem of finasteride transfer in semen. This warning has since been removed from the package insert. Considering the medical/legal implications of a theoretically possible link of finasteride treatment to birth defects, it is reasonable to assume that Merck & Co. must be very confident in knowing that impregnating a woman while taking finasteride absolutely does not cause birth defects.

 

Nor is there any evidence of birth defects when the father taking finasteride has intercourse with the pregnant mother during the critical periods of sexual development. The in utero effects of finasteride exposure during the period of embryonic and fetal development (gestation days 20-100) were evaluated in the rhesus monkey, a species fairly predictive of human development. Intravenous administration of finasteride to pregnant monkeys at doses as high as 800ng/day (at least 60 to 120 times the highest estimated exposure of pregnant women to finasteride from semen of men taking 5mg/day) caused no abnormalities in male fetuses.

 

Still, Merck retains this admonition: "Women should not handle crushed or broken Propecia tablets when they are pregnant or may be potentially pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus. Propecia tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed."

 

Considering that intravenous administration of finasteride to pregnant experimental animals during the critical periods of sexual development didn't cause birth defects, there is no reason to believe that transdermal absorption of finasteride from handling broken tablets could cause birth defects in the male child. But, since Propecia has not been approved by the FDA for use by women, Merck has nothing to lose by retaining this warning. In fact, it has good p.r. value.

 

So, can finasteride cause birth defects? Yes, there is a theoretical possibility that it can, but the probability is close to nil, when finasteride is taken in the recommended dosages. Since Propecia was approved by the FDA on 22 December 1997 and Proscar on 28 August 1996, millions of doses of finasteride have been taken and there has not been a single case report of a birth defect. Now that's reassuring information.

 

Richard Lee, M.D.

 

 

Andersson, S.; Berman, D. M.; Jenkins, E. P.; Russell, D. W.: Deletion of steroid 5-alpha-reductase 2 gene in male pseudohermaphroditism. Nature 354: 159-161, 1991

Greene, S. A.; Symes, E.; Brook, C. G. D.: 5-Alpha-reductase deficiency causing male pseudohermaphroditism. Arch. Dis. Child. 53: 751-753, 1978

Imperato-McGinley, J.; Gautier, T.: Inherited 5-alpha-reductase deficiency in man. Trends Genet. 2: 130-133, 1986

Moore, KL and Persaud, TVN: Before We Are Born-Essentials of Embryology and Birth Defects; 6th Edition, Saunders 2003

New England J of Med: 1994, Jan 13; 330 (2) 120-5

Physicians Desk Reference, 58th Edition, 2004, pp. 2172-2178

Thigpen, A. E.; Davis, D. L.; Milatovich, A.; Mendonca, B. B.; Imperato-McGinley, J.; Griffin, J. E.; Francke, U.; Wilson, J. D.; Russell, D. W.: The molecular genetics of steroid 5-alpha-reductase 2 deficiency. J. Clin. Invest. 90: 799-809, 1992

http://encarta.msn.com/encyclopedia_761580700/Human_Sexuality.html#endads

http://science.howstuffworks.com/human-reproduction5.htm

Sex-organ development is determined by the third month of development.

http://www.people.virginia.edu/~rjh9u/sexdev.html

http://www.lindasy.com/cgi-local/SoftCart.100.exe/skin4...dec01.html?E+scstore

[taker]

so in other words there is a close to nil chance of a birth defect if the male is taking Finasteride during conception, the sensitive stages, or pretty much the entire pregnancy.

We just need to keep the woman away from the tablets dust.

 

Of course, if you are concerned, than stop taking it if you are trying to conceive throughout the first 4 months, but it is more of a mental thing.

 

Is that what I am taking from this?

[ttaco]

I took finasteride every day and my wife and I conceived a healthy baby boy 2 years ago. No problems.