Danocrine Pregnancy Warnings
Use is contraindicated.
AU TGA pregnancy category: D
US FDA pregnancy category: X
Comments:
-Use of adequate methods of non-hormonal contraception should be encouraged.
-If the patient becomes pregnant while taking this drug, treatment should be discontinued and the patient should be apprised of the potential harm to the fetus.
One animal model failed to reveal evidence of embryotoxicity or teratogenicity at doses 7 to 15 times the human dose, while a different animal model revealed evidence of fetal development inhibition at doses 2 to 4 times the human dose given on days 6 to 18 of gestation. Exposure to female fetuses may result in virilization (e.g., clitoral hypertrophy, labial fusion, urogenital sinus defect, vaginal atresia, ambiguous genitalia). There are no controlled data in human pregnancy.
Modest reductions in spermatogenesis and abnormalities in semen volume, viscosity, sperm count, and motility have occurred in male patients receiving long-term treatment.
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.
See references
