Magazine article from our research archive:

FDA announces labeling changes for Regranex.(Warnings/recalls)(Food and Drug Administration)

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 ...

Related newspaper, magazine, and journal articles:

See all results. Or, try our Advanced Search.

Newsweek Harper's Magazine The Washington Post Chicago Tribune Crain's Chicago Business PRNewswire Pediatric News The Nation Advertising Age The Economist (US) A FREE trial gives you access to over 60 million articles! Access over 3,500 publications with a FREE trial!