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Spironolactone Pregnancy and Breastfeeding Warnings

Spironolactone is also known as: Aldactone

Spironolactone Pregnancy Warnings

Spironolactone has been assigned to pregnancy category C by the FDA. Animal studies at the maximum human dose showed feminization of male fetuses during early pregnancy and indications of endocrine dysfunction in both male and female offspring during late pregnancy that persisted into adulthood. Diuretics, in general, are contraindicated in pregnancy, except when necessary in patients with cardiovascular disease, since they do not prevent or alter the course of toxemia and they may cause a decrease in placental perfusion. There are no controlled data in human pregnancy. Spironolactone is only recommended for use in pregnancy when there are no alternatives and benefit outweighs risk.

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Spironolactone Breastfeeding Warnings

Spironolactone has been found to be tumorigenic in rats and canrenone, the major (and active) metabolite of spironolactone appears in human breast milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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References for pregnancy information

  1. Groves TD, Corenblum B "Spironolactone therapy during human pregnancy." Am J Obstet Gynecol 172 (1995): 1655-6
  2. Phelps DL, Karim Z "Spironolactone: relationship between concentrations of dethioacetylated metabolite in human serum and milk." J Pharm Sci 66 (1977): 1203
  3. "Product Information. Aldactone (spironolactone)." Searle, Skokie, IL.
  4. Messina M, Biffignandi P, Ghigo E, Jeantet MG, Molinatti GM "Possible contraindication of spironolactone during pregnancy." J Endocrinol Invest 2 (1979): 222
  5. Lammintausta R, Erkkola R "Effect of spironolactone treatment on the renin-aldosterone system during pregnancy." Int J Clin Pharmacol Biopharm 17 (1979): 294-8
  6. Christianson R, Page EW "Diuretic drugs and pregnancy." Obstet Gynecol 48 (1976): 647-52

References for breastfeeding information

  1. Roberts RJ, Blumer JL, Gorman RL, et al "American Academy of Pediatrics Committee on Drugs: Transfer of drugs and other chemicals into human milk." Pediatrics 84 (1989): 924-36
  2. Phelps DL, Karim Z "Spironolactone: relationship between concentrations of dethioacetylated metabolite in human serum and milk." J Pharm Sci 66 (1977): 1203
  3. "Product Information. Aldactone (spironolactone)." Searle, Skokie, IL.

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