Regranex Gel 0.01% (becaplermin), a cream used to treat diabetic foot ulcers, will now carry a “boxed warning” on its label after a study found a greater number of cancer-related deaths in frequent users of the drug, the U.S. Food and Drug Administration announced Friday.
Patients using three or more tubes of Regranex had a five-fold higher risk of cancer mortality than non-users.
"However, the risk of getting new cancers among Regranex users was not increased compared to non-users," according to an FDA statement. "The duration of follow-up of patients in this study was not long enough to detect new cancers."
Ortho-McNeil and Ethicon, Inc. issued a letter to doctors to clarify how the drug should be used.
"In announcing this label change, FDA still cautions health care professionals to carefully weigh the risks and benefits of treating patients with Regranex," said Susan Walker, MD, director of the Division of Dermatological and Dental Products, in a prepared statement. "Regranex is not recommended for patients with known malignancies."
The drug was approved by the FDA in 1997 and is a genetically engineered version of human platelet-derived growth factor, a normally occurring molecule that spurs cell growth in the body.