Vabon Use In Pregnancy & Lactation

Use in pregnancy: Category X.
VABON may cause fetal harm when administered to pregnant woman. Androgenic effects including clitoral hypertrophy, labial fusion of the external genital fold to form a scrotal-like structure, ambiguous genitalia, abnormal vaginal development, and persistence of a urogenital sinus have occurred in the female offspring of woman who were given VABON during pregnancy. Spontaneous abortions have also occurred in pregnant woman who received the drug. Since the risks clearly outweigh the possible benefits in woman who are or may become pregnant, VABON is contraindicated in such woman. Woman of childbearing age should be instructed to use an effective, non hormonal method of contraception during VABON therapy and be informed of the potential hazard to the fetus should they become pregnant during therapy. In addition, a reliable pregnancy test must be performed immediately prior to beginning VABON therapy. If the drug is inadvertently administered during pregnancy or if the patient becomes pregnant while receiving the drug, administration of VABON should be discontinued, and the woman should be apprised of the potential risk to the fetus.
Use in nursing mother: Breast-feeding is contraindicated in patients taking VABON. Because of the potential for serious adverse reactions to VABON in nursing infants, a decision should be made whether to discontinue nursing or not use the drug, taking into account the importance of the drug to the woman.