CLINICAL - Male Reproductive Endocrinology II &Amp; Case Reports 2011
DOI: 10.1210/endo-meetings.2011.part3.p27.p3-227
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Ambiguous Genitalia in a Newborn with Spironolactone Exposure

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Cited by 12 publications
(7 citation statements)
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“…Spironolactone is listed by the FDA as a pregnancy category C drug because feminization of newborn male rats has been documented. However, only one human case has been reported where treatment with spironolactone in pregnancy led to ambiguous genitalia in a male infant due to spironolactone treatment for polycystic ovary syndrome prepregnancy and through the fifth week of gestation . Eplerenone is listed by the FDA as a pregnancy category B drug.…”
Section: Pa In the Setting Of Pregnancymentioning
confidence: 99%
“…Spironolactone is listed by the FDA as a pregnancy category C drug because feminization of newborn male rats has been documented. However, only one human case has been reported where treatment with spironolactone in pregnancy led to ambiguous genitalia in a male infant due to spironolactone treatment for polycystic ovary syndrome prepregnancy and through the fifth week of gestation . Eplerenone is listed by the FDA as a pregnancy category B drug.…”
Section: Pa In the Setting Of Pregnancymentioning
confidence: 99%
“…3 A single case of ambiguous genitalia in a human male newborn whose mother was treated with spironolactone until the fifth week of gestation has been reported. 14…”
Section: Discussionmentioning
confidence: 99%
“…3 A single case of ambiguous genitalia in a human male newborn whose mother was treated with spironolactone until the fifth week of gestation has been reported. 14 Unlike spironolactone, eplerenone does not bind to the androgen receptor. No teratogenic effects or demasculinisation were seen in male rabbit or rat fetuses when dams were dosed at approximately 30 times the equivalent of a human dose of 100 mg/day.…”
Section: Discussionmentioning
confidence: 99%
“…In rats treated with a high dose of spironolactone, feminization of male rat fetuses was observed [ 10 ]. One case report described ambiguous genitalia in a human newborn of a mother treated with spironolactone during pregnancy [ 11 ]. However, no association with sirenomelia is known for the two drugs given to our case.…”
Section: Discussionmentioning
confidence: 99%