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Aminoglutethimide Pregnancy and Breastfeeding Warnings

Brand names: Cytadren

Aminoglutethimide Pregnancy Warnings

Aminoglutethimide has been assigned to pregnancy category D. Animal studies have revealed evidence of embryocidal, fetotoxic and teratogenic effects. There are no controlled data in human pregnancy. Inhibition of steroid synthesis is of concern in the development of a normal fetus. Pseudohermaphroditism is reported in female infants exposed to aminoglutethimide in utero. Aminoglutethimide should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

A possible association between maternal use of aminoglutethimide during pregnancy and female pseudohermaphroditism has been reported. In one case report, aminoglutethimide was used until the eight month of pregnancy. In another case, aminoglutethimide was used throughout pregnancy. In both cases, the mothers also received phenytoin and mephobarbital.

In two other case reports, first and second trimester exposure was not associated with virilization of the female fetus.

See references

Aminoglutethimide Breastfeeding Warnings

There are no data on the excretion of aminoglutethimide into human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions due to aminoglutethimide 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.

See references

References for pregnancy information

  1. LeMaire WJ, Cleveland WW, Bejar RL, Marsh JM, Fishman L. Aminoglutethimide: a possible cause of pseudohermaphroiditism in females. Am J Dis Child. 1972;124:421-3.
  2. Product Information. Cytadren (aminoglutethimide). Ciba Self-Medication Inc. 2002;PROD.
  3. Iffy L, Ansell S, Bryant JS, Herrmann WL. Nonadrenal female pseudohermaphroditism: an unusual case of fetal masculinization. Obstet Gynecol. 1965;26:59-65.
  4. Marek J, Horky K. Aminoglutethimide administration in pregnancy. Lancet. 1970;2:1312-3.
  5. Hanson TJ, Ballonoff LB, Northcutt RC. Amino-glutethimide and pregnancy. JAMA. 1974;230:963-4.

References for breastfeeding information

  1. Product Information. Cytadren (aminoglutethimide). Ciba Self-Medication Inc. 2002;PROD.

Further information

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