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This is a FDA article re: new warning that is being sent out to Doctors along with a 'Black Box' to be included on the patient insert for Nolvadex.
BE SURE TO CLICK ON THE LINKS!!!
{Bold added by me.}
Nolvadex [tamoxifen citrate]
Audience: Oncologists and other healthcare professionals caring for women with breast cancer
FDA and AstraZeneca have 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. [/b}
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
http://www.fda.gov/medwatch/SAFETY/2002/nolvadex_deardoc.pdf
[May 16, 2002] Full, Revised Label - AstraZeneca
http://www.fda.gov/cder/foi/label/2002/17970s37s44s49lbl.pdf
[May 16, 2002] Patient Package Insert - AstraZeneca
http://www.fda.gov/cder/foi/label/2002/17970s37s44s49ppilbl.pdf
BE SURE TO CLICK ON THE LINKS!!!
{Bold added by me.}
Nolvadex [tamoxifen citrate]
Audience: Oncologists and other healthcare professionals caring for women with breast cancer
FDA and AstraZeneca have 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. [/b}
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
http://www.fda.gov/medwatch/SAFETY/2002/nolvadex_deardoc.pdf
[May 16, 2002] Full, Revised Label - AstraZeneca
http://www.fda.gov/cder/foi/label/2002/17970s37s44s49lbl.pdf
[May 16, 2002] Patient Package Insert - AstraZeneca
http://www.fda.gov/cder/foi/label/2002/17970s37s44s49ppilbl.pdf
