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FDA announces labeling changes for Regranex.(Warnings/recalls)(Food and Drug Administration)
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Adverse Event Reporting News
- Article date:
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June 17, 2008
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Copyright informationCOPYRIGHT 2008 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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FDA announced June 6 the addition of a boxed warning to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer mortality in patients who use three or more tubes of the product. Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients.
The WARNINGS section of the product has been updated to include a BOXED WARNING and a description of the epidemiologic data that are the basis for the revised label. These data come from a retrospective study that compared cancer incidence and cancer mortality among 1,622 patients exposed to Regranex to 2,809 otherwise similar patients who were not ...
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FDA ANNOUNCES NEW LABELING CHANGES FOR REGRANEX
US Fed News Service, Including US State News;
June 6, 2008 ;
596 words
......to the label of Regranex Gel 0.01% (becaplermin...increased risk of cancer mortality in patients who...incidence and cancer mortality among 1,622 patients exposed to Regranex to 2,809 otherwise...patients exposed to Regranex. However, there...increased risk of cancer ...
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FDA Announces New Labeling Changes for Regranex Product to carry boxed...
M2 Presswire;
June 9, 2008 ;
652 words
......to the label of Regranex Gel 0.01% (becaplermin...increased risk of cancer mortality in patients who...incidence and cancer mortality among 1,622 patients exposed to Regranex to 2,809 otherwise...patients exposed to Regranex. However, there...increased risk of cancer ...
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Boxed warning added to foot/leg ulcer gel.(News)
Skin & Allergy News;
July 1, 2008 ;
Mechcatie, Elizabeth;
553 words
......incidence and cancer mortality among 1,622 patients...treated with Regranex with 2,809 similar...treated with Regranex. The incidence...those in the Regranex group, but the risk of cancer mortality was five times...more tubes of Regranex. No single type...who had used ...
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Boxed warning added to diabetic ulcer treatment.(News)
Family Practice News;
July 1, 2008 ;
Mechcatie, Elizabeth;
559 words
......incidence and cancer mortality among 1,622 patients...treated with Regranex to 2,809 similar...treated with Regranex. The incidence...those in the Regranex group, but the risk of cancer mortality was five times...more tubes of Regranex. No single type...who had used ...
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CDC report on cancer mortality surveillance.(Practice Guideline...
American Family Physician;
October 15, 2004 ;
Morantz, Carrie Torrey, Brian;
365 words
......Prevention (CDC) has released a new report on cancer mortality entitled, Cancer Mortality Surveillance--United States, 1990-2000...decade. Considerable variation exists in cancer mortality between the sexes and among different...
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Trends in cancer mortality during the 20th century in Australia
Australian Health Review;
November 1, 2007 ;
Freak-Poli, Rosanne; Bi, Peng; Hiller, Janet E;
787 words
......was conducted, using annual cancer mortality data over the period 1907...explore change in Australian cancer mortality. A 3-year moving average...results suggested that overall cancer mortality rose slightly over the past...
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Cancer mortality in the South. (review from Southern Medical Journal,...
American Family Physician;
September 1, 1990 ;
370 words
...Cancer Mortality in the South From 1950 to 1980, cancer mortality in the southern United States differed substantially...of the country. During this period, the overall cancer mortality rate for men rose twice as rapidly in the South...
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Vitamin D does not reduce overall cancer mortality
The Hindustan Times;
October 31, 2007 ;
347 words
......has no beneficial effect on overall cancer mortality, according to a study done by the...the theory that vitamin D can reduce cancer mortality by decreasing cancer incidence or...order to find any association between cancer mortality and elevated levels of vitamin D...
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Mammography Reduces Breast Cancer Mortality.(Brief Article)
Family Practice News;
June 1, 2001 ;
FINN, ROBERT;
389 words
......contributed to a 63% decline in breast cancer mortality in a study of breast cancer deaths...to a nearly 50% reduction in breast cancer mortality, which is significantly greater than...of about 24 months. Overall, breast cancer mortality fell significantly by 50% among all...
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Sen. Hagel Introduces Lung Cancer Mortality Reduction Act
US Fed News Service, Including US State News;
July 1, 2008 ;
787 words
......Nebraska, has introduced the Lung Cancer Mortality Reduction Act of 2008 (S. 3187), legislation...interagency response to reduce lung cancer mortality in a timely manner." The bill, introduced...full-text of the legislation follows:Lung Cancer Mortality Reduction Act of 2008S. 3187To ...
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Smoking, Fibrinogen and Cancer Mortality
Journal of the National Medical Association;
April 1, 2007 ;
Everett, Charles J; Wells, Brian J; Frithsen, Ivar L; Koopman, Richelle J;
787 words
......history and fibrinogen levels with cancer mortality were investigated prospectively using...of respiratory/intrathoracic organ cancer mortality than nonblack current heavy smokers...of respiratory/intrathoracic organ cancer mortality when compared to nonblack former heavy...
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Breast Cancer Mortality Rates Down in Canada
Xinhua English Newswire;
July 28, 1997 ;
229 words
...Breast cancer mortality rates in Canada have reached...significant decreases in breast cancer mortality rates occurred in all age groups...role in the decline of breast cancer mortality rates," the agency noted. The...
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Why do breast cancer mortality rates vary across states?
The American Surgeon;
January 1, 2003 ;
Maggard, Melinda A; Thompson, Jesse E; Ko, Clifford Y;
787 words
......state-to-state variations in breast cancer mortality rates the reasons for such differences...objective was to confirm whether breast cancer mortality rates are significantly different...rates. State-level variation in breast cancer mortality rates was demonstrated in the NCHS...
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NCI Atlas of Cancer Mortality in the United States.(National Cancer...
American Family Physician;
June 15, 2000 ;
Preboth, Monica;
148 words
......published a book titled the Atlas of Cancer Mortality in the United States, 1950-94. The...rates, allow physicians to compare cancer mortality rates over several decades and provide...that break down the distribution of cancer mortality rates by gender, race and age are...
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U.S. Cancer Mortality for Top 15 Sites, 1990-98
The World Almanac and Book of Facts 2002;
132 words
...The World Almanac and Book of Facts 2002 01-01-2002 Title: U.S. Cancer Mortality for Top 15 Sites, 1990-98 U.S. Cancer Mortality for Top 15 Sites, 1990-98 Source: Surveillance, Epidemiology, and End Results (SEER...
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