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Progesterone Pregnancy and Breastfeeding Warnings

Progesterone is also known as: Crinone, Cyclogest, Endometrin, First Progesterone MC10, First Progesterone MC5, Gestone, Menopause Formula Progesterone, Prochieve, Progest, Prometrium

Medically reviewed on March 26, 2018.

Progesterone Pregnancy Warnings

Use is contraindicated. (Prometrium(R) - US)
Use is not recommended. (Utrogestan (R) oral capsules, Cylcogest (R) 200 mg pessaries - UK)

Use is recommended only during the first trimester of pregnancy as part of an assisted reproduction (ART) regimen.


AU TGA pregnancy category: A
US FDA pregnancy category: B

Comments:
-Use only during the first 3 months of pregnancy.
-This drug has been used to support embryo implantation and pregnancy maintenance.
-This drug should not be needed once there is adequate secretion of placental progesterone.

Animal studies revealed little to no evidence of fetal harm or impaired fertility, however genital abnormalities (hypospadias and virilization) have been reported in fetuses of animals treated during gestation. Birth defects reported during clinical trials include cleft palate, intrauterine growth retardation, spina bifida, congenital heart defects, umbilical hernia, intestinal anomaly, esophageal fistula, hypospadias, underdeveloped right ear, Down's and atrial septal defect, DiGeorge's syndrome, and hand deformity; up to 3.4% of children in the studies had birth defects. Studies done with assisted reproductive technology (ART) (oocyte transfer procedures and in-vitro fertilization) showed one congenital malformation associated with a chromosomal abnormality, spontaneous abortions, teratoma associated with cleft palate, and respiratory distress syndrome; most newborns were apparently normal. Another pivotal trial has a 4.5% rate (7 cases/404 patients) of fetal anomalies: esophageal fistula, cleft palate/cleft lip, hydrocephalus and holoprosencephaly/proboscis/polydactylia). Use of progesterone is not associated with masculinization of female fetuses. Rates of congenital abnormalities, spontaneous abortion, and ectopic pregnancies seen in clinical trials are similar to the event rates in the general population. There are no known deleterious effects on fertility.

AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

See references

Progesterone Breastfeeding Warnings

Use is not recommended.

Excreted into human milk: Yes

Comments:
-Detectable amounts of progesterone enter breast milk; effects on the infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Prometrium (progesterone)." Virtus Pharmaceuticals LLC, Tampa, FL.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Crinone (progesterone)." Actavis U.S. (Alpharma USPD), Owings Mills, MD.
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. "Product Information. Endometrin (progesterone)." Ferring Pharmaceuticals Inc, Tarrytown, NY.

References for breastfeeding information

  1. "Product Information. Prometrium (progesterone)." Virtus Pharmaceuticals LLC, Tampa, FL.
  2. "Product Information. Endometrin (progesterone)." Ferring Pharmaceuticals Inc, Tarrytown, NY.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. "Product Information. Crinone (progesterone)." Actavis U.S. (Alpharma USPD), Owings Mills, MD.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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