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Medroxyprogesterone Pregnancy and Breastfeeding Warnings

Medroxyprogesterone is also known as: Amen, Curretab, Cycrin, Depo-Provera, Depo-Provera Contraceptive, Provera, depo-subQ provera 104

Medroxyprogesterone Pregnancy Warnings

Studies in animals have shown that progestogens, including this drug, may have an adverse effect on the developing fetus, including teratogenicity and fetotoxicity. Other animal studies have shown that high doses of progestogens can cause masculinization of the female fetus. There may be increased risks for hypospadias, clitoral enlargement and labial fusion in children of mothers exposed to medroxyprogesterone (MPA) tablets during the first trimester of pregnancy. However, a clear association between these conditions with use of MPA tablets has not been established. A significant increase in polysyndactyly and chromosomal anomalies was observed among infants of injection users, being most pronounced in women under 30 years of age; however, a causal association unlikely. Children and neonates exposed to this drug in-utero and followed to adolescence showed no evidence of any adverse effects on their health including their physical, intellectual, sexual or social development. 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 X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Use is contraindicated. AU TGA pregnancy category: D US FDA pregnancy category: -Oral tablets: Pregnancy X -IM and SC injection: Not assigned Comments: -Evaluate the potential hazard to the fetus if this drug is used during pregnancy, or if pregnancy occurs while using this drug. -Consider the possibility of an ectopic pregnancy among women using IM injection, who become pregnant or complain of severe abdominal pain. -Infants from accidental pregnancies that occur 1 to 2 months after injection with this drug may be at increased risk of low birth weight, and may be associated with an increased risk of neonatal death.

See references

Medroxyprogesterone Breastfeeding Warnings

Use is not recommended. Excreted into human milk: Yes Comments: -The effects in the nursing infant are unknown.

Although this drug is detectable in the maternal milk, its composition, quality, and amount are not adversely affected. Neonates and infants exposed to this drug from breast milk have been studied for developmental and behavioral effects through puberty, and no adverse effects have been noted.

See references

References for pregnancy information

  1. Pardthaisong T, Yenchit C, Gray R "The long-term growth and development of children exposed to Depo- Provera during pregnancy or lactation." Contraception 45 (1992): 313-24
  2. Resseguie LJ, Hick JF, Bruen JA, Noller KL, O'Fallon WM, Kurland LT "Congenital malformations among offspring exposed in utero to progestins, Olmsted County, Minnesota, 1936-1974." Fertil Steril 43 (1985): 514-9
  3. Jaffe B, Shye D, Harlap S, Baras M, Lieblich A "Aggression, physical activity levels and sex role identity in teenagers exposed in utero to MPA." Contraception 40 (1989): 351-63
  4. "Product Information. Provera (medroxyprogesterone)." Pharmacia and Upjohn, Kalamazoo, MI.
  5. Katz Z, Lancet M, Skornik J, Chemke J, Mogilner BM, Klinberg M "Teratogenicity of progestogens given during the first trimester of pregnancy." Obstet Gynecol 65 (1985): 775-80
  6. Jaffe B, Harlap S, Baras M, Gordon L, Lieblich A, Magidor S, Sanchez M "Long-term effects of MPA on human progeny: intellectual development." Contraception 37 (1988): 607-19
  7. "Product Information. Depo-Provera (medroxyprogesterone)." Pharmacia and Upjohn, Kalamazoo, MI.
  8. Pardthaisong T, Gray RH "In utero exposure to steroid contraceptives and outcome of pregnancy" Am J Epidemiol 134 (1991): 795-803
  9. Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
  10. Yovich JL, Turner SR, Draper R "Medroxyprogesterone acetate therapy in early pregnancy has no apparent fetal effects." Teratology 38 (1988): 135-44
  11. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  12. Jordan A "Toxicology of depot medroxyprogesterone acetate." Contraception 49 (1994): 189-201
  13. "Product Information. depo-subQ provera 104 (medroxyPROGESTERone (medroxyprogesterone))." Pfizer U.S. Pharmaceuticals Group, New York, NY.
  14. "Product Information. MedroxyPROGESTERone Acetate (medroxyPROGESTERone (medroxyprogesterone))." Greenstone LLC, Peapack, NJ.
  15. Gray RH, Pardthaisong T "In utero exposure to steroid contraceptives and survival during infancy" Am J Epidemiol 134 (1991): 804-11
  16. Cerner Multum, Inc. "Australian Product Information." O 0
  17. Schwallie PC "The effect of depot-medroxyprogesterone acetate on the fetus and nursing infant: a review." Contraception 23 (1981): 375-86

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. MedroxyPROGESTERone Acetate (medroxyPROGESTERone (medroxyprogesterone))." Greenstone LLC, Peapack, NJ.
  3. Schwallie PC "The effect of depot-medroxyprogesterone acetate on the fetus and nursing infant: a review." Contraception 23 (1981): 375-86
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. Hefnawi F, Fawzi G, Badraoui MH "Effect of some progestational steroids on lactation in Egyptian women. I. Milk yield during the first year of lactation." J Biosoc Sci 8 (1976): 45-8
  6. Abdel Kader MM, Abdel Aziz MT, Bahgat R, Hefnawi F, Fawzi G, Badraoui MH "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 (1976): 49-51
  7. Dahlberg K "Some effects of depo-medroxyprogesterone acetate (DMPA): observations in the nursing infant and in the long-term user." Int J Gynaecol Obstet 20 (1982): 43-8
  8. Jimenez J, Ochoa M, Soler MP, Portales P "Long-term follow-up of children breast-fed by mothers receiving depot- medroxyprogesterone acetate." Contraception 30 (1984): 523-33
  9. Shaaban MM "Contraception with progestogens and progesterone during lactation." J Steroid Biochem Mol Biol 40 (1991): 705-10
  10. "Product Information. Provera (medroxyprogesterone)." Pharmacia and Upjohn, Kalamazoo, MI.
  11. "Product Information. Depo-Provera (medroxyprogesterone)." Pharmacia and Upjohn, Kalamazoo, MI.
  12. Koetsawang S, Nukulkarn P, Fotherby K, Shrimanker K, Mangalam M, Towobola K "Transfer of contraceptive steroids in milk of women using long-acting gestagens." Contraception 25 (1982): 321-31
  13. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
  14. "Product Information. depo-subQ provera 104 (medroxyPROGESTERone (medroxyprogesterone))." Pfizer U.S. Pharmaceuticals Group, New York, NY.

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