posted July 02, 2000 01:24 PM            

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This is just some info that people might want to know about.

Effects on the liver: Liver cancer: In the Swedish trial using adjuvant NOLVADEX 40 mg/day for 2-5 years, 3 cases of liver cancer have been reported in the NOLVADEX-treated group vs. 1 case in the observation group (See PRECAUTIONS-Carcinogenesis). In other clinical trials evaluating NOLVADEX, no cases of liver cancer have been reported to date.

No cases of liver cancer were reported in NSABP P-1 with a median follow-up of 4.2 years.

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.

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