Propecia and child berth
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Dinzy
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Are you sure about this? Now I know that pregnant woman should not come in contact with finasteride so my question comes down to how can finasteride be transfered form a man to a woman in such a way that it enters her bloodstream. Is it present in saliva and semen?
Now obviously the best advice is to stay away from anything that can lead to birth defects when your wife is carrying a child but the fact that there is no warning on any of the commercials about a man taking finasteride and having sex w/ a pregnant woman leading to birth defects leads me to wonder whether or not it is in fact safe. Certainly if there is no warning and there is still a risk of the birth defect then they are leaving themselves open for a class action lawsuit.
Now obviously the best advice is to stay away from anything that can lead to birth defects when your wife is carrying a child but the fact that there is no warning on any of the commercials about a man taking finasteride and having sex w/ a pregnant woman leading to birth defects leads me to wonder whether or not it is in fact safe. Certainly if there is no warning and there is still a risk of the birth defect then they are leaving themselves open for a class action lawsuit.
Dinzy
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Britannia said:
I understand all that.
So why isn't there a warning to this effect in the ads and such in the US. I recently saw an ad for Avodart and all they mentioned was sexual side effects, tender nipples and that pregnant woman should not handle broken tablets. IIRC the same warning was in the Propecia ads. Now I am asuming this means it needs to be orally ingested in order to get into the bloodstream and become a risk for birth defects. Why else would they not mention such a thing?
Obviously I am just being a***, but I prefer to know the exact risk rather than just a general fact that finasteride can disrupt a developing fetus's hormones and lead to a serious birth defect. Personally I would dump all my finasteride and thoroughly clean the bathroom if I was going to have a kid.
tobyhope
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Britannia said:
Are you kidding me? Is it really present in semen? This is just very alarming to me. Do you have any facts to back up that statement? I have tried to research this very same topic and came across a few and the worse I read was that finasteride could be present in semen but in a very very little amount that could not cause harm. Please, please provide any facts that you may have because this means I will have to quit taking finasteride.
thanks
Britannia
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tobyhope said:
Hi. I remember a good few years ago I worked at a small DGH in and we had a patient probably about 65ish who took Proscar for BPH and wanted to start a family. He was told by his Dr (a Urologist) that he should discontinue his Proscar because of the risk of finasteride being transferred to his partner. There are only a few studies out there about finasteride being present in semen, and I appreciate that Proscar is five times stronger than Propecia but I certainely think its a risk that needs addressing. I have never known a case where a fetus has been negatively affected by finasteride, but theoretically the risk is there. I suggest to anyone who is worried about this to talk to their Drs. This is a time when getting advice from people on an public forum should be take a back seat to the knowledge and experience of an MD.
As I understand it, though it is dangerous for a woman to handle the tablets whilst pregnant, finasteride cannot be transmitted to a woman through semen
Initially there was a question over whether this was safe or not, and Merck recommended not to have sex with someone taking Propecia if you wanted to concieve - mainly to cover themselves. But they have since shown that it is not a risk, and that is why they no longer warn against it.
As has already been stated Merck would have opened temselves to absolute f*cking bankruptcy if there was at least one iota of truth in the idea that Propecia causes birth defects.
Yes DHT is vital in the formation of the male foetus, but finasteride is not present in the semen.
I'm not an expert so maybe somebody has a more detailled explanation.
As for saying that we should contact our doctors Brit - thats a bit difficult when most of us are taking this medication without prescription & without medical consultation.
In addition, though I take your point that: "This is a time when getting advice from people on an public forum should be take a back seat to the knowledge and experience of an MD", unfortunately, in the UK at least, there are very few GPs who actually know sh*t about Propecia.
Initially there was a question over whether this was safe or not, and Merck recommended not to have sex with someone taking Propecia if you wanted to concieve - mainly to cover themselves. But they have since shown that it is not a risk, and that is why they no longer warn against it.
As has already been stated Merck would have opened temselves to absolute f*cking bankruptcy if there was at least one iota of truth in the idea that Propecia causes birth defects.
Yes DHT is vital in the formation of the male foetus, but finasteride is not present in the semen.
I'm not an expert so maybe somebody has a more detailled explanation.
As for saying that we should contact our doctors Brit - thats a bit difficult when most of us are taking this medication without prescription & without medical consultation.
In addition, though I take your point that: "This is a time when getting advice from people on an public forum should be take a back seat to the knowledge and experience of an MD", unfortunately, in the UK at least, there are very few GPs who actually know sh*t about Propecia.
Here are some articles on the issue - enjoy
Use during pregnancy
'Propecia' is contra-indicated for use in women due to the risk in pregnancy.
Because of the ability of type II 5α-reductase inhibitors to inhibit conversion of testosterone to dihydrotestosterone (DHT) in some tissues, these drugs, including finasteride, may cause abnormalities of the external genitalia of a male foetus when administered to a pregnant woman.
Exposure to finasteride: risk to male foetus
A small amount of finasteride, less than 0.001% of the 1 mg dose per ejaculation, has been detected in the seminal fluid of men taking 'Propecia'. Studies in Rhesus monkeys have indicated that this amount is unlikely to constitute a risk to the developing male foetus (see Section 5.3).
During continual collection of adverse experiences, post-marketing reports of exposure to finasteride during pregnancy via semen of men taking 1 mg or higher doses have been received for eight live male births, and one retrospectively-reported case concerned an infant with simple hypospadias. Causality cannot be assessed on the basis of this single retrospective report and hypospadias is a relatively common congenital anomaly with an incidence ranging from 0.8 to 8 per 1000 live male births. In addition, a further nine live male births occurred during clinical trials following exposure to finasteride via semen, during pregnancy, and no congenital anomalies have been reported.
Crushed or broken tablets of 'Propecia' should not be handled by women when they are or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male foetus. 'Propecia' tablets are coated to prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed.
Use during lactation
'Propecia' is contraindicated for use in lactation.
http://emc.medicines.org.uk/emc/assets/ ... entid=3680
Finasteride: Does it affect spermatogenesis and pregnancy?
Meena Pole, MD Gideon Koren, MD, FRCPC
December, 2001
ABSTRACT
QUESTION A few women have asked me whether finasteride, taken by their partners for male pattern baldness, will affect their pregnancies. The product monograph is very alarming: it sounds as if even handling the medication could cause harm, especially to a male fetus. Should a man stop taking finasteride if his partner is planning pregnancy or is pregnant? What is the risk to the fetus if its mother accidentally handles crushed or broken tablets?
ANSWER
To date, there are no reports of adverse pregnancy outcomes among women exposed to finasteride. Taking 1 mg of finasteride daily did not have any clinically significant effect on menÕs semen. Absorption through the skin while handling tablets is extremely unlikely to cause fetal exposure or harm. There is no reason to discontinue the drug. Motherisk is currently following up women who are pregnant or planning pregnancy and whose partners are taking finasteride.
Finasteride, an oral type II 5-reductase inhibitor, selectively blocks androgen activity in the prostate and skin and hence is potentially useful for treating male pattern baldness, hirsutism, and acne.1 Hirsute womenÕs skin shows heightened 5-reductase activity,2 so finasteride could be used to treat them also.
Finasteride, a potent competitive 5-reductase inhibitor, reduces testosterone metabolism to dihydrotestosterone (DHT).1,3 This is an important step because baldness is not known to occur unless testosterone is converted to dihydrotestosterone. Finasteride decreases circulating DHT without decreasing testosterone.3
Dihydrotestosterone is responsible for acne, increases of body and facial hair during puberty, prostate gland growth, and development of male genitalia in utero. Use of finasteride is, therefore, contraindicated for pregnant women or women trying to become pregnant.1
Risk of exposure
Finasteride is absorbed mainly from the gastrointestinal tract, is not affected by food, and has a bioavailability ranging from 60% to 80%. It is highly bound to protein and undergoes extensive metabolism by hepatic cytochrome P-450 enzymes. It is mainly eliminated through bile and feces (60% to 80%) with minimal renal excretion (no dose adjustment is needed for elderly patients or patients with renal impairment). Its mean serum half-life ranges from 4.7 to 7.1 h but, because its biologic half-life is much longer, DHT might be suppressed for nearly 2 weeks after discontinuing it.3
In one study, semen levels were measured in 35 men taking 1 mg of finasteride daily for 6 weeks.4 Highest level measured was 1.52ng/mL; mean level was 0.26 ng/mL. Assuming a 100% vaginal absorption through a 5-mL ejaculate per day, women would be exposed to 7.6ng/d, a negligible amount. This level is 750 times lower than the Òno effectÓ level for developmental abnormalities in rhesus monkeys.4 Consequences of exposure
Similarly, animal studies conducted by the drugÕs manufacturer of giving 800 ng/d of finasteride intravenously (750 times the highest estimated exposure of pregnant women from semen of men taking 1 mg/d) to monkeys found no abnormalities among male fetuses.4 To confirm the relevance of results in rhesus monkeys for human fetal development, pregnant monkeys were administered high oral doses of finasteride (2 mg/kg/d, which is equivalent to 100 times the recommended human dose of 1 mg/d, or 12 million times the highest estimated exposure from semen of men taking 1amg/d). Results showed abnormalities in male external genitalia, but no other abnormalities and no effect on female fetuses.
In 1999, a double-blind, randomized placebo-controlled multicentre study was conducted on 181 men between 19 and 41 years old. These men received 1 mg/d of finasteride or placebo for 48 weeks (4 spermatogenic cycles) and no drugs for the following 60 weeks. Among these 181 men, 79 were included in a supset for collection and analysis of sequential semen samples. Results showed that 1 mg/d of finasteride did not have any significant effect on sperm concentration, total sperm per ejaculate, or sperm motility or morphology.5
The absence of clinically significant effects of 1 mg/d of finasteride on semen parameters supports the hypothesis that testosterone and not DHT is the primary androgen regulating spermatogenesis, sperm maturation, and seminal fluid production.4,5 Similarly, men with 5-reductase deficiency have lifelong (including in utero) suppression of DHT formation, with low serum DHT levels and mildly elevated testosterone levels. Their other morphologic features include rudimentary prostates, small seminal vesicles, normal epididymal size, and markedly diminished volume of ejaculate.6,7
The notable decrease in volume of ejaculate in these men was attributed to in utero reduction of DHT, which led to development of a rudimentary prostate gland. In the absence of any other anatomic abnormalities, these men have been shown to have normal spermatogenesis and healthy progeny.6-9 Side effects reported with finasteride were mainly related to sexual dysfunction; effects were mild and disappeared after treatment was discontinued.3
Women also become alarmed after reading finasterideÕs label or product monograph. They are afraid to handle crushed or broken tablets, especially during pregnancy.4 Tablets, however, are coated with film, so risk of absorption of finasteride through the skin is negligible and is unlikely to cause harm to a fetus.
No drug interactions have been reported with finasteride. Hirsute women taking oral contraceptives who were treated with finasteride showed a marked elevation in serum cholesterol levels. Finasteride alone did not produce this effect.10
In the future, finasteride could be used to treat acne and hirsutism in women.10,11 Women using finasteride should be advised to use contraception to avoid pregnancy and hence the risk of feminization of male fetusesÕ external genitalia. To date, no study has explored the effect of 5-reductase inhibitors on hirsute patients.
References
Amichai B, Grunwald MH, Sobel R. 5 alpha-reductase inhibitorsÑa new hope in dermatology? Int J Dermatol 1997;36:182-4.
Mowszowicz I, Melanitou E, Doukani A, Wright F, Kuttenn F, Mauvais-Jarvis P. Androgen binding capacity and 5 alpha-reductase activity in pubic skin fibroblasts from hirsute patients. J Clin Endocrinol Metab 1983;56:1209-13.
Cather JC, Lane D, Heaphy MR Jr, Nelson BR. Finasteride: an update and review. Cutis 1999;64:167-72.
Merck Frosst Canada & Co. PropeciaÑdiscontinuation prior to/during pregnancy. Dorval, Que: Merck Frosst Canada; 2000.
Overstreet JW, Fuh WL, Gould J, Howards SS, Lieber MM, Hellstrom W, et al. Chronic treatment with finasteride daily does not affect spermatogenesis or semen production in young men. J Urol 1999;162:1295-300.
Imperato-McGinley J, Guerrero L, Gautier T, Peterson RE. Steroid 5s-reductase deficiency in man: an inherited form of male pseudohermaphroditism. Science 1974;186:1213-5.
Walsh PC, Madden JD, Harrod MJ, Goldstein JL, MacDonald PC, Wilson JD. Familial incomplete male pseudohermaphroditism, type 2. Decreased dihydrotestosterone formation in pseudovaginal perineoscrotal hypospadias. N Engl J Med 1974;291:944-9.
Katz MD, Kligman I, Cai LQ, Zhu YS, Fratianni CM, Zervoudakis I, et al. Paternity by intrauterine insemination with sperm from a man with 5 -reductase 2 deficiency. N Engl J Med 1997;336:994-7.
Ivarrson SA, Nielsen MD, Lindberg T. Male pseudohermaphroditism due to 5 alpha-reductase deficiency in a Swedish family. Eur J Pediatr 1988;147:532-5.
Moghetti P, Castello R, Magnani CM, Tosi F, Negri C, Armanini D, et al. Clinical and hormonal effects of 5 -reductase inhibitor finasteride in idiopathic hirsutism. J Clin Endocrinol Metab 1994;79:1115-21.
Serafini P, Ablan F, Lobo RA. 5 alpha-reductase activity in the genital skin of hirsute women. J Clin Endocrinol Metab 1985;60:349-55.
Use during pregnancy
'Propecia' is contra-indicated for use in women due to the risk in pregnancy.
Because of the ability of type II 5α-reductase inhibitors to inhibit conversion of testosterone to dihydrotestosterone (DHT) in some tissues, these drugs, including finasteride, may cause abnormalities of the external genitalia of a male foetus when administered to a pregnant woman.
Exposure to finasteride: risk to male foetus
A small amount of finasteride, less than 0.001% of the 1 mg dose per ejaculation, has been detected in the seminal fluid of men taking 'Propecia'. Studies in Rhesus monkeys have indicated that this amount is unlikely to constitute a risk to the developing male foetus (see Section 5.3).
During continual collection of adverse experiences, post-marketing reports of exposure to finasteride during pregnancy via semen of men taking 1 mg or higher doses have been received for eight live male births, and one retrospectively-reported case concerned an infant with simple hypospadias. Causality cannot be assessed on the basis of this single retrospective report and hypospadias is a relatively common congenital anomaly with an incidence ranging from 0.8 to 8 per 1000 live male births. In addition, a further nine live male births occurred during clinical trials following exposure to finasteride via semen, during pregnancy, and no congenital anomalies have been reported.
Crushed or broken tablets of 'Propecia' should not be handled by women when they are or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male foetus. 'Propecia' tablets are coated to prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed.
Use during lactation
'Propecia' is contraindicated for use in lactation.
http://emc.medicines.org.uk/emc/assets/ ... entid=3680
Finasteride: Does it affect spermatogenesis and pregnancy?
Meena Pole, MD Gideon Koren, MD, FRCPC
December, 2001
ABSTRACT
QUESTION A few women have asked me whether finasteride, taken by their partners for male pattern baldness, will affect their pregnancies. The product monograph is very alarming: it sounds as if even handling the medication could cause harm, especially to a male fetus. Should a man stop taking finasteride if his partner is planning pregnancy or is pregnant? What is the risk to the fetus if its mother accidentally handles crushed or broken tablets?
ANSWER
To date, there are no reports of adverse pregnancy outcomes among women exposed to finasteride. Taking 1 mg of finasteride daily did not have any clinically significant effect on menÕs semen. Absorption through the skin while handling tablets is extremely unlikely to cause fetal exposure or harm. There is no reason to discontinue the drug. Motherisk is currently following up women who are pregnant or planning pregnancy and whose partners are taking finasteride.
Finasteride, an oral type II 5-reductase inhibitor, selectively blocks androgen activity in the prostate and skin and hence is potentially useful for treating male pattern baldness, hirsutism, and acne.1 Hirsute womenÕs skin shows heightened 5-reductase activity,2 so finasteride could be used to treat them also.
Finasteride, a potent competitive 5-reductase inhibitor, reduces testosterone metabolism to dihydrotestosterone (DHT).1,3 This is an important step because baldness is not known to occur unless testosterone is converted to dihydrotestosterone. Finasteride decreases circulating DHT without decreasing testosterone.3
Dihydrotestosterone is responsible for acne, increases of body and facial hair during puberty, prostate gland growth, and development of male genitalia in utero. Use of finasteride is, therefore, contraindicated for pregnant women or women trying to become pregnant.1
Risk of exposure
Finasteride is absorbed mainly from the gastrointestinal tract, is not affected by food, and has a bioavailability ranging from 60% to 80%. It is highly bound to protein and undergoes extensive metabolism by hepatic cytochrome P-450 enzymes. It is mainly eliminated through bile and feces (60% to 80%) with minimal renal excretion (no dose adjustment is needed for elderly patients or patients with renal impairment). Its mean serum half-life ranges from 4.7 to 7.1 h but, because its biologic half-life is much longer, DHT might be suppressed for nearly 2 weeks after discontinuing it.3
In one study, semen levels were measured in 35 men taking 1 mg of finasteride daily for 6 weeks.4 Highest level measured was 1.52ng/mL; mean level was 0.26 ng/mL. Assuming a 100% vaginal absorption through a 5-mL ejaculate per day, women would be exposed to 7.6ng/d, a negligible amount. This level is 750 times lower than the Òno effectÓ level for developmental abnormalities in rhesus monkeys.4 Consequences of exposure
Similarly, animal studies conducted by the drugÕs manufacturer of giving 800 ng/d of finasteride intravenously (750 times the highest estimated exposure of pregnant women from semen of men taking 1 mg/d) to monkeys found no abnormalities among male fetuses.4 To confirm the relevance of results in rhesus monkeys for human fetal development, pregnant monkeys were administered high oral doses of finasteride (2 mg/kg/d, which is equivalent to 100 times the recommended human dose of 1 mg/d, or 12 million times the highest estimated exposure from semen of men taking 1amg/d). Results showed abnormalities in male external genitalia, but no other abnormalities and no effect on female fetuses.
In 1999, a double-blind, randomized placebo-controlled multicentre study was conducted on 181 men between 19 and 41 years old. These men received 1 mg/d of finasteride or placebo for 48 weeks (4 spermatogenic cycles) and no drugs for the following 60 weeks. Among these 181 men, 79 were included in a supset for collection and analysis of sequential semen samples. Results showed that 1 mg/d of finasteride did not have any significant effect on sperm concentration, total sperm per ejaculate, or sperm motility or morphology.5
The absence of clinically significant effects of 1 mg/d of finasteride on semen parameters supports the hypothesis that testosterone and not DHT is the primary androgen regulating spermatogenesis, sperm maturation, and seminal fluid production.4,5 Similarly, men with 5-reductase deficiency have lifelong (including in utero) suppression of DHT formation, with low serum DHT levels and mildly elevated testosterone levels. Their other morphologic features include rudimentary prostates, small seminal vesicles, normal epididymal size, and markedly diminished volume of ejaculate.6,7
The notable decrease in volume of ejaculate in these men was attributed to in utero reduction of DHT, which led to development of a rudimentary prostate gland. In the absence of any other anatomic abnormalities, these men have been shown to have normal spermatogenesis and healthy progeny.6-9 Side effects reported with finasteride were mainly related to sexual dysfunction; effects were mild and disappeared after treatment was discontinued.3
Women also become alarmed after reading finasterideÕs label or product monograph. They are afraid to handle crushed or broken tablets, especially during pregnancy.4 Tablets, however, are coated with film, so risk of absorption of finasteride through the skin is negligible and is unlikely to cause harm to a fetus.
No drug interactions have been reported with finasteride. Hirsute women taking oral contraceptives who were treated with finasteride showed a marked elevation in serum cholesterol levels. Finasteride alone did not produce this effect.10
In the future, finasteride could be used to treat acne and hirsutism in women.10,11 Women using finasteride should be advised to use contraception to avoid pregnancy and hence the risk of feminization of male fetusesÕ external genitalia. To date, no study has explored the effect of 5-reductase inhibitors on hirsute patients.
References
Amichai B, Grunwald MH, Sobel R. 5 alpha-reductase inhibitorsÑa new hope in dermatology? Int J Dermatol 1997;36:182-4.
Mowszowicz I, Melanitou E, Doukani A, Wright F, Kuttenn F, Mauvais-Jarvis P. Androgen binding capacity and 5 alpha-reductase activity in pubic skin fibroblasts from hirsute patients. J Clin Endocrinol Metab 1983;56:1209-13.
Cather JC, Lane D, Heaphy MR Jr, Nelson BR. Finasteride: an update and review. Cutis 1999;64:167-72.
Merck Frosst Canada & Co. PropeciaÑdiscontinuation prior to/during pregnancy. Dorval, Que: Merck Frosst Canada; 2000.
Overstreet JW, Fuh WL, Gould J, Howards SS, Lieber MM, Hellstrom W, et al. Chronic treatment with finasteride daily does not affect spermatogenesis or semen production in young men. J Urol 1999;162:1295-300.
Imperato-McGinley J, Guerrero L, Gautier T, Peterson RE. Steroid 5s-reductase deficiency in man: an inherited form of male pseudohermaphroditism. Science 1974;186:1213-5.
Walsh PC, Madden JD, Harrod MJ, Goldstein JL, MacDonald PC, Wilson JD. Familial incomplete male pseudohermaphroditism, type 2. Decreased dihydrotestosterone formation in pseudovaginal perineoscrotal hypospadias. N Engl J Med 1974;291:944-9.
Katz MD, Kligman I, Cai LQ, Zhu YS, Fratianni CM, Zervoudakis I, et al. Paternity by intrauterine insemination with sperm from a man with 5 -reductase 2 deficiency. N Engl J Med 1997;336:994-7.
Ivarrson SA, Nielsen MD, Lindberg T. Male pseudohermaphroditism due to 5 alpha-reductase deficiency in a Swedish family. Eur J Pediatr 1988;147:532-5.
Moghetti P, Castello R, Magnani CM, Tosi F, Negri C, Armanini D, et al. Clinical and hormonal effects of 5 -reductase inhibitor finasteride in idiopathic hirsutism. J Clin Endocrinol Metab 1994;79:1115-21.
Serafini P, Ablan F, Lobo RA. 5 alpha-reductase activity in the genital skin of hirsute women. J Clin Endocrinol Metab 1985;60:349-55.
EasyEd
Established Member
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Is there anybody in this forum at all that impregnated his wife/girlfriend/whoever while on finasteride and has some actual proof of any of this? I plan on having kids within the next year or two and would really like to hear from someone who has actual experience on the matter. Please help out!
strikernr
Member
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A lot of people have asked similar questions about propecia at askdocweb.com. I haven't gone through the entire log but i suspect you might find an answer to your concern here...
http://www.askdocweb.com/propecia2.html
http://www.askdocweb.com/propecia2.html
EasyEd
Established Member
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I'm seeing answers coming from both directions on this matter. Some are saying that conceiving while on finasteride cause birth defects and others are saying it does not. Which is it? How can we find out for sure? I can ask my doctor but regardless of what he says, I'll know that I've been told otherwise and that he might be wrong. Does anybody know from actual experience of conceiving a child while on finasteride?
SarcasticHorse
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I remember my doctor was very adament about me keeping the actual propecia pills away from any pregnant women, saying, "pregnant women shouldn't even be in the same room as propecia pills because even touching them can cause birth defects."
He didn't say anything about being with girls while on the drug, however...
He didn't say anything about being with girls while on the drug, however...