J&J's Regranex Ups Cancer Mortality Risk: FDA

Law360, New York (June 9, 2008, 12:00 AM EDT) -- The U.S. Food and Drug Administration has added its most serious warning to Johnson & Johnson's Regranex after a study indicated that although diabetics who use large amounts of the foot ulcer gel may not be more likely to develop cancer, if they do, they are five times more likely to die of it.

The agency said Friday it had added a black box warning to the label of Regranex 0.01% gel – a topical cream for the treatment of leg and foot ulcers that are...
To view the full article, register now.