Ortho-McNeil, a subsidiary of Johnson & Johnson, this week sent letters to physicians notifying them of a boxed warning for Regranex, a cream used to treat diabetic ulcers on the legs and feed.
The warning reads: "An increased risk of mortality secondary to malignancy was observed in patients treated with three or more tubes of Regranex gel in a post-marketing retrospective cohort study. Regranex gel should only be used when the benefits can be expected to outweigh the risks. Regranex gel should be used with caution in patients with known malignancy."
Regranex (becaplermin) is a recombinant form of human platelet?derived growth factor that is applied directly to foot and leg ulcers that fail to heal. Because growth factors cause cells to divide rapidly, FDA has had J&J track the drug for possible effects on cancers, starting before the drug was approved in 1997. A previous study, concluded in 2001, showed an increase in the number of cancers in patients using Regranex.
According to Jackie Jankewicz, public relations director for Ethicon, an operating company of J&J, the current warning is based on a recently completed study based on insurance company records of 1,622 patients treated with Regranex, and a control group of 2,809 patients.
"In a small subgroup of patients that were exposed to three or more tubes of the gel, there was an increased risk of cancer mortality," Jankewicz told Pharm Exec. "However, this was not the gold-standard prospective study, and the study didn?t show an increase in cancer."
FDA concluded that the risk of death by cancer was about five times higher in patients using three tubes or more of Regranex, compared with those who had used none. But it also pointed out that ulcers are a leading cause of hospitalization for diabetic patients. "Diabetic ulcers can be a very serious condition, and are a leading cause of hospitalization for patients. This is the only approved medication that includes this growth factor that helps the body heal when applied to an ulcer," Jankewicz said.