Tamoxen Use In Pregnancy & Lactation

Pregnancy: Tamoxifen (TAMOXEN) must not be administered during pregnancy. There have been a small number of reports of spontaneous abortions, birth defects and foetal deaths after women have taken Tamoxifen (TAMOXEN), although no causal relationship has been established.
Reproductive toxicology studies in rats, rabbits and monkeys have shown no teratogenic potential.
In rodent models of foetal reproductive tract development, Tamoxifen (TAMOXEN) was associated with changes similar to those caused by oestradiol, ethinylestradiol, clomiphene and diethylstilboestrol (DES). Although the clinical relevance of these changes is unknown, some of them, especially vaginal adenosis, are similar to those seen in young women who were exposed to DES in utero and who have a 1 in 1000 risk of developing clear-cell carcinoma of the vagina or cervix. Only a small number of pregnant women have been exposed to Tamoxifen (TAMOXEN). Such exposure has not been reported to cause subsequent vaginal adenosis or clear-cell carcinoma of the vagina or cervix in young women exposed in utero to Tamoxifen (TAMOXEN).
Women should be advised not to become pregnant whilst taking Tamoxifen (TAMOXEN) and should use barrier or other non-hormonal contraceptive methods if sexually active. Premenopausal patients must be carefully examined before treatment to exclude pregnancy. Women should be appraised of the potential risks to the foetus, should they become pregnant whilst taking Tamoxifen (TAMOXEN) or within two months of cessation of therapy.
Breast-feeding: It is not known if Tamoxifen (TAMOXEN) is excreted in human milk and therefore the drug is not recommended during breast-feeding. The decision either to discontinue nursing or discontinue Tamoxifen (TAMOXEN) should take into account the importance of the drug to the mother.