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

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