Last week the US Food and Drug Administration announced an ongoing safety review of the the drug Regranex (becaplermin), a medication commonly used by diabetics to treat foot and leg ulcers.
According to the FDA there may be evidence showing an increased risk of death from cancer in patients who have used Regranex, a product made by Johnson & Johnson for diabetic ulcers. The information was gathered by analyzing medical records from diabetics who have been treated with Regranex and comparing the data with other patients who have diabetes but have not used Regranex.
“In this study, among those who were prescribed Regranex three or more times, there was an increase in the number of patients who died as a result of cancer. There was not enough information to say whether there was an increase in the number of patients that developed new cancers.”
– Food and Drug Administration press release.
Regranex is a medication that is applied directly to diabetic foot and leg ulcers that are not healing. It is a synthetic version of the platelet growth factor that is produced naturally in the human body. Platelet growth factor helps heal ulcers, and causes cells to divide more rapidly. Regranex was approved in December 1997. In a long term safety study completed in 2001, there were more cancers in people who used Regranex than in those who did not use it.