The U.S. Food and Drug Administration (FDA) has said that it has received study information that may increase the risk of cancer in patients with diabetes who applied the topical drug, Regranex, directly to their foot or leg. It is currently reviewing the situation.

What is Regranex?

Regranex (becaplermin) is a medicine that is a recombinant (genetically engineered) form of human platelet-derived growth factor which is applied directly to diabetic foot and leg ulcers that are not healing. According to a press release on the FDA’s website (www.fda.gov/), “The recombinant form of platelet growth factor has a biologic activity that is much like that produced naturally by the body. Growth factors cause cells to divide more rapidly. It is for this reason that the manufacturer continued to monitor studies begun before Regranex was approved in December 1997 for any evidence of adverse effects such as increased numbers of cancers.”

Several studies done

The FDA reported that several studies have been done concerning Regranex and that it is currently conducting another. Below is information on each:

• 2001: 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.
  
• 2003: Following the report of the study completed in 2001, an additional study was performed using a health insurance database that covered the period from January, 1998 through June, 2003. This study used the database to identify two groups of patients with similar diagnoses, drug use, and use of health services, one of which used Regranex and one group that did not.
  
  The FDA states that the results of this study showed that deaths from cancer were higher for patients who were given three or more prescriptions for treatment with Regranex than those who were not treated with Regranex. No single type of cancer was identified, but rather deaths from all types of cancer, combined were observed.
  
• 2008: On 3/27/08, the FDA posted the statement that it is conducting a safety review based on study data suggesting there may be an increased risk of death from cancer in diabetic patients using Regranex Gel. It recommends that health care professionals discuss the potential risks and benefits of using Regranex with their patients while the current review is ongoing.