Pregnancy & Lactation : הריון/הנקה

4.6    Fertility, pregnancy and lactation


Women of childbearing potential
Women should be advised not to become pregnant whilst taking Tamoxifen Teva and for nine months following the cessation of therapy 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 informed of the potential risks to the foetus, should they become pregnant whilst taking Tamoxifen Teva or within nine months of cessation of therapy.

Pregnancy
Tamoxifen Teva 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, 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 was associated with changes similar to those caused by estradiol, 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. 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.


Breast-feeding
Limited data suggest that Tamoxifen Teva and its active metabolites are excreted and 
accumulate over time in human milk, therefore the drug is not recommended during breast-feeding. The decision either to discontinue nursing or discontinue Tamoxifen Teva should take into account the importance of the drug to the mother.