Crinone Pregnancy Warnings
Products intended as part of an assisted reproduction (ART) regimen are recommended only during the first trimester of pregnancy. Otherwise, they should not be used during pregnancy.
Other product forms are not recommended or are contraindicated during pregnancy.
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
