The risk of death from cancer may be increased in patients prescribed becaplermin (Regranex) more than three times, according to statement by the Food and Drug Administration issued last month.
Becaplermin is made by Johnson & Johnson's Ethicon division and is used to treat diabetic leg and foot ulcers. It was approved in 1997.
In a posting on its Web site, the agency said it recently was informed of a study—an analysis of a health insurance database—that found an increase in the number of cancer deaths in patients taking becaplermin. The database contained information on adult patients with diabetes who had no history of cancer. The authors compared patients taking becaplermin with those who did not. There were more cancer deaths in those prescribed the drug three or more times. It is not clear whether there was an increase in new cancer cases, said the FDA.
Johnson & Johnson had already been monitoring a potential cancer link, as becaplermin, a recombinant form of human platelet-derived growth factor, inherently had the potential to accelerate disease. Growth factors cause cells to divide more rapidly, said the FDA.
A long-term safety study completed by Johnson & Johnson in 2001 found more cancer in patients prescribed the drug.
The agency said patients should not stop taking the drug. Instead, “the risk of using Regranex should be weighed against the benefit for each individual patient.” The agency has not yet decided whether the new data will lead to any labeling changes.