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Conjugated estrogens / medroxyprogesterone Pregnancy and Breastfeeding Warnings

Brand names: Premphase, Premphase 14/14, Prempro

Medically reviewed by Drugs.com. Last updated on Feb 6, 2024.

Conjugated estrogens / medroxyprogesterone Pregnancy Warnings

This drug is not indicated for use during pregnancy

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned

Risk Summary: This drug is not indicated for use in females of reproductive potential; there appears to be little or no increased risk of birth defects in women who have used estrogens and progestins as an oral contraceptive inadvertently during early pregnancy.

Comments:
-If pregnancy occurs, this drug should be discontinued.

Animal studies have shown high doses of progestins can cause masculinization of the female fetus. Epidemiologic studies and meta-analyses have not shown exposure to combined hormonal contraceptives (estrogen and progestins) increases the risk of genital or non-genital birth defects with exposure before conception or during pregnancy. This drug is not indicated for use in females of reproductive potential. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Conjugated estrogens / medroxyprogesterone Breastfeeding Warnings

This drug is not indicated for use in lactating females

Excreted into human milk: Yes

See references

See also

References for pregnancy information

  1. Heinonen O, Shapiro S; Kaufman DW ed., Slone D (1977) "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc., p. 297
  2. Gray RH, Pardthaisong T (1991) "In utero exposure to steroid contraceptives and survival during infancy" Am J Epidemiol, 134, p. 804-11
  3. Pardthaisong T, Gray RH (1991) "In utero exposure to steroid contraceptives and outcome of pregnancy" Am J Epidemiol, 134, p. 795-803
  4. Resseguie LJ, Hick JF, Bruen JA, Noller KL, O'Fallon WM, Kurland LT (1985) "Congenital malformations among offspring exposed in utero to progestins, Olmsted County, Minnesota, 1936-1974." Fertil Steril, 43, p. 514-9
  5. Katz Z, Lancet M, Skornik J, Chemke J, Mogilner BM, Klinberg M (1985) "Teratogenicity of progestogens given during the first trimester of pregnancy." Obstet Gynecol, 65, p. 775-80
  6. Pardthaisong T, Yenchit C, Gray R (1992) "The long-term growth and development of children exposed to Depo- Provera during pregnancy or lactation." Contraception, 45, p. 313-24
  7. Schwallie PC (1981) "The effect of depot-medroxyprogesterone acetate on the fetus and nursing infant: a review." Contraception, 23, p. 375-86
  8. Jaffe B, Shye D, Harlap S, Baras M, Lieblich A (1989) "Aggression, physical activity levels and sex role identity in teenagers exposed in utero to MPA." Contraception, 40, p. 351-63
  9. Jaffe B, Harlap S, Baras M, Gordon L, Lieblich A, Magidor S, Sanchez M (1988) "Long-term effects of MPA on human progeny: intellectual development." Contraception, 37, p. 607-19
  10. Yovich JL, Turner SR, Draper R (1988) "Medroxyprogesterone acetate therapy in early pregnancy has no apparent fetal effects." Teratology, 38, p. 135-44
  11. Jordan A (1994) "Toxicology of depot medroxyprogesterone acetate." Contraception, 49, p. 189-201
  12. (2001) "Product Information. Depo-Provera (medroxyprogesterone)." Pharmacia and Upjohn
  13. (2001) "Product Information. Provera (medroxyprogesterone)." Pharmacia and Upjohn
  14. (2001) "Product Information. Premarin (conjugated estrogens)." Wyeth-Ayerst Laboratories

References for breastfeeding information

  1. Jimenez J, Ochoa M, Soler MP, Portales P (1984) "Long-term follow-up of children breast-fed by mothers receiving depot- medroxyprogesterone acetate." Contraception, 30, p. 523-33
  2. Koetsawang S, Nukulkarn P, Fotherby K, Shrimanker K, Mangalam M, Towobola K (1982) "Transfer of contraceptive steroids in milk of women using long-acting gestagens." Contraception, 25, p. 321-31
  3. Schwallie PC (1981) "The effect of depot-medroxyprogesterone acetate on the fetus and nursing infant: a review." Contraception, 23, p. 375-86
  4. Dahlberg K (1982) "Some effects of depo-medroxyprogesterone acetate (DMPA): observations in the nursing infant and in the long-term user." Int J Gynaecol Obstet, 20, p. 43-8
  5. Abdel Kader MM, Abdel Aziz MT, Bahgat R, Hefnawi F, Fawzi G, Badraoui MH (1976) "Effect of some progestational steroids on lactation in Egyptian women. II. Chemical composition of milk during the first year of lactation." J Biosoc Sci, 8, p. 49-51
  6. Hefnawi F, Fawzi G, Badraoui MH (1976) "Effect of some progestational steroids on lactation in Egyptian women. I. Milk yield during the first year of lactation." J Biosoc Sci, 8, p. 45-8
  7. Shaaban MM (1991) "Contraception with progestogens and progesterone during lactation." J Steroid Biochem Mol Biol, 40, p. 705-10
  8. Committee on Drugs, 1992 to 1993 (1994) "The transfer of drugs and other chemicals into human milk." Pediatrics, 93, p. 137-50
  9. (2001) "Product Information. Depo-Provera (medroxyprogesterone)." Pharmacia and Upjohn
  10. (2001) "Product Information. Provera (medroxyprogesterone)." Pharmacia and Upjohn

Further information

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