Dermavax Use In Pregnancy & Lactation

Pregnancy: Pregnancy is an absolute contraindication to treatment with isotretinoin (see Contraindications). Women of childbearing potential have to use effective contraception during and up to one month after treatment. If pregnancy does occur in spite of these precautions during treatment with DERMAVAX or in the month following, there is a great risk of very severe and serious malformation of the foetus.
The foetal malformations associated with exposure to isotretinoin include central nervous system abnormalities (hydrocephalus, cerebellar malformation/abnormalities, microcephaly), facial dysmorphia, cleft palate, external ear abnormalities (absence of external ear, small or absent external auditory canals), eye abnormalities (microphthalmia), cardiovascular abnormalities (conotruncal malformations such as tetralogy of Fallot, transposition of great vessels, septal defects), thymus gland abnormality and parathyroid gland abnormalities. There is also an increased incidence of spontaneous abortion.
If pregnancy occurs in a woman treated with isotretinoin, treatment must be stopped and the patient should be referred to a physician specialised or experienced in teratology for evaluation and advice.
Breastfeeding: Isotretinoin is highly lipophilic, therefore the passage of isotretinoin into human milk is very likely. Due to the potential for adverse effects in the child exposed via mothers' milk, DERMAVAX is contraindicated during breast-feeding (see Contraindications).
Fertility: Isotretinoin, in therapeutic dosages, does not affect the number, motility and morphology of sperm and does not jeopardise the formation and development of the embryo on the part of the men taking isotretinoin.