Propecia and Pregnancy, is it safe?

Article by HairlossTalk.com

Propecia is already Long Gone

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.

Intercourse During Pregnancy

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.”

In Conclusion

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/skin411/411_dec01.html?E+scstore

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