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One case of liver cancer was reported in NSABP P-1 in a participant randomized to Nolvadex. Effects on the liver: Non-malignant effects: Nolvadex has been associated with changes in liver enzyme levels, and on rare occasions, a spectrum of more severe liver abnormalities including fatty liver, cholestasis, hepatitis and hepatic necrosis. A few of these serious cases included fatalities. In most reported cases the relationship to Nolvadex is uncertain. However, some positive rechallenges and dechallenges have been reported. In the NSABP P-1 trial, few grade 3-4 changes in liver function (SGOT, SGPT, bilirubin, alkaline phosphatase) were observed (10 on placebo and 6 on Nolvadex). Serum lipids were not systematically collected. Other cancers: A number of second primary tumors, occurring at sites other than the endometrium, have been reported following the treatment of breast cancer with Nolvadex in clinical trials. Data from the NSABP B-14 and P-1 studies show no increase in other (non-uterine) cancers among patients receiving Nolvadex. Whether an increased risk for other (non-uterine) cancers is associated with Nolvadex is still uncertain and continues to be evaluated. Effects on the Eye: Ocular disturbances, including corneal changes, decrement in color vision perception, retinal vein thrombosis, and retinopathy have been reported in patients receiving Nolvadex. An increased incidence of cataracts and the need for cataract surgery have been reported in patients receiving Nolvadex. In the NSABP P-1 trial, an increased risk of borderline significance of developing cataracts among those women without cataracts at baseline (540-Nolvadex; 483-placebo; RR=1, where to buy domestic steroids. Among these same women, Nolvadex was associated with an increased risk of having cataract surgery (101-Nolvadex; 63-placebo; RR=1. Among all women on the trial (with or without cataracts at baseline), Nolvadex was associated with an increased risk of having cataract surgery (201-Nolvadex; 129-placebo; RR=1. Eye examinations were not required during the study. No other conclusions regarding non-cataract ophthalmic events can be made. Pregnancy Category D: Nolvadex may cause fetal harm when administered to a pregnant woman. Women should be advised not to become pregnant while taking Nolvadex or within 2 months of discontinuing Nolvadex and should use barrier or nonhormonal contraceptive measures if sexually active. Tamoxifen does not cause infertility, even in the presence of menstrual irregularity. Effects on reproductive functions are expected from the antiestrogenic properties of the drug. In reproductive studies in rats at dose levels equal to or below the human dose, nonteratogenic developmental skeletal changes were seen and were found reversible. 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