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Generic
Name |
Tamoxifen |
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Trade Name |
Nolvadex |
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Manufacturer |
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Risk
Category |
|
| D |
- Positive evidence of human fetal risk exists.
- Potential benefits may warrant use of the drug in pregnant women despite potential risks (e.g. life threatening situations or serious illness).
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Indication |
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- Non-steroidal anti-estrogen, antineoplastic for treatment of breast cancer.
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Fetal Risk
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 |
- Carcinogenic
in animals producing ovarian, testicular tumors and hepatocellular carcinoma; and producing endometrial cancer in humans.
- Not teratogenic in animals but fetotoxic, causing growth retardation, prematurity, abortions and fetal death.
- Causes impaired fertility and decreases implantation rate in animals and abnormalities in sexual differentiation of female fetuses including gonadal and genitourinary tract abnormalities (atrophic ovaries and uterus, vaginal adenosis).
- Limited data in human pregnancy. A case has been reported of ambiguous genitalia in female fetus exposed in the first 20 weeks of gestation and a case of Goldenhar’s syndrome (occuloauriculo-vertebral anomaly) in infant exposed to it in utero during the first two trimesters to Tamoxifen.
- Higher incidence of abortions occurs in pregnancies following chemotherapy with Tamoxifen but successful outcome may result if pregnancy occurs more than two months after Tamoxifen therapy.
- Offsprings exposed in utero to Tamoxifen require long-term follow-up because of potential carcinogenicity.
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Breast Feeding
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 |
- Inhibits lactation.
- Contraindicated during nursing.
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