Medroxyprogesterone Pregnancy and Breastfeeding Warnings
Brand names: Amen, Curretab, Cycrin, Depo Provera, Provera, depo-subQ provera 104
Medically reviewed by Drugs.com. Last updated on Mar 29, 2024.
Medroxyprogesterone Pregnancy Warnings
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.
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.
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 also
References for pregnancy information
- Heinonen O, Shapiro S; Kaufman DW ed., Slone D (1977) "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc., p. 297
- Gray RH, Pardthaisong T (1991) "In utero exposure to steroid contraceptives and survival during infancy" Am J Epidemiol, 134, p. 804-11
- Pardthaisong T, Gray RH (1991) "In utero exposure to steroid contraceptives and outcome of pregnancy" Am J Epidemiol, 134, p. 795-803
- 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
- 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
- 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
- Schwallie PC (1981) "The effect of depot-medroxyprogesterone acetate on the fetus and nursing infant: a review." Contraception, 23, p. 375-86
- 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
- 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
- Yovich JL, Turner SR, Draper R (1988) "Medroxyprogesterone acetate therapy in early pregnancy has no apparent fetal effects." Teratology, 38, p. 135-44
- Jordan A (1994) "Toxicology of depot medroxyprogesterone acetate." Contraception, 49, p. 189-201
- (2001) "Product Information. Depo-Provera (medroxyprogesterone)." Pharmacia and Upjohn
- (2001) "Product Information. Provera (medroxyprogesterone)." Pharmacia and Upjohn
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- Cerner Multum, Inc. "Australian Product Information."
- (2022) "Product Information. MedroxyPROGESTERone Acetate (medroxyPROGESTERone)." Greenstone LLC
- (2022) "Product Information. depo-subQ provera 104 (medroxyPROGESTERone)." Pfizer U.S. Pharmaceuticals Group
References for breastfeeding information
- 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
- 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
- Schwallie PC (1981) "The effect of depot-medroxyprogesterone acetate on the fetus and nursing infant: a review." Contraception, 23, p. 375-86
- 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
- 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
- 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
- Shaaban MM (1991) "Contraception with progestogens and progesterone during lactation." J Steroid Biochem Mol Biol, 40, p. 705-10
- Committee on Drugs, 1992 to 1993 (1994) "The transfer of drugs and other chemicals into human milk." Pediatrics, 93, p. 137-50
- (2001) "Product Information. Depo-Provera (medroxyprogesterone)." Pharmacia and Upjohn
- (2001) "Product Information. Provera (medroxyprogesterone)." Pharmacia and Upjohn
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- Cerner Multum, Inc. "Australian Product Information."
- (2022) "Product Information. MedroxyPROGESTERone Acetate (medroxyPROGESTERone)." Greenstone LLC
- (2022) "Product Information. depo-subQ provera 104 (medroxyPROGESTERone)." Pfizer U.S. Pharmaceuticals Group
Further information
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