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U.S. Department of Health and Human Services

Safety

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Nolvadex (tamoxifen citrate)

Audience: Oncologists and other healthcare professionals caring for women with breast cancer

FDA and AstraZeneca added a boxed warning and strengthened the WARNINGS section of the label to inform healthcare professionals about new risk information of particular relevance to women with ductal carcinoma in situ [DCIS] and women at high risk for developing breast cancer and are receiving or considering Nolvadex therapy to reduce their risk of developing invasive breast cancer.

Serious, life-threatening or fatal events associated with Nolvadex in the risk reduction setting [women at high risk for cancer and women with DCIS] include endometrial cancer, uterine sarcoma, stroke, and pulmonary embolism. Healthcare providers should discuss the potential benefits versus the potential risks of these serious events with women considering Nolvadex to reduce their risk of developing breast cancer.

[May 15, 2002 - Letter - AstraZeneca]
[May 16, 2002 - Full, Revised Label - AstraZeneca]