Thought some people would be interested in the letter of complaint I sent to the FDA several months ago. I don't think most patients know what "women years" are. The black box label states the risk of uterine sarcoma in the P-1 trial as 0.17 in the tam arm vs. 0.0 in the placebo arm per 1,000 women-years. I think my change is more comprehensible. Labels must be made comprehensible to patients and doctors alike. Also the uterine sarcoma risk was not even listed in the patient section. Helen Schiff Breast Cancer Advocate 20 E. 9th St. #15B New York City, New York 10003 Dr. Richard Pazdur Food and Drug Administration Division of Oncology Drugs HFD 150 5600 Fishers Lane Rockville, Maryland 20857 Dear Dr. Pazdur: The risk of uterine sarcoma in women taking tamoxifen (as well as the other risks) should be more clearly expressed in the black box warning and in terms that are understandable to a layperson. Instead of expressing the risk in "women years," which is unlikely to be understood, I suggest the following: With a median follow up of 6.9 years of the Tamoxifen Risk Reduction Trial, there were 4 cases of uterine sarcoma in the (put in number) women with an intact uterus who were taking tamoxifen and zero cases of uterine sarcoma in the (put in number) women with an intact uterus taking a placebo. You might also want to include the median length of time that women were on the drug. Also, the uterine sarcoma information should be noted in the patient information section of the label. In the future, labels should be understandable to people without a medical and/or statistical background. It might be helpful to routinely show them to laypeople before they are issued. Thank you very much. Sincerely, Helen Schiff Breast Cancer Advocate cc: Robert Temple Susan Honig Patty Delaney Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.