Safety review to be conducted on gel for diabetic foot and leg ulcers

The FDA announced yesterday that it is conducting a safety review of Regranex Gel (becaplermin), a recombinant form of human platelet-derived growth factor used to heal foot and leg ulcers in patients with diabetes.

The March 27 safety review announcement comes amidst study findings that indicate an increased risk of death from cancer in patients who have repeatedly used Regranex (Ortho-McNeil Pharmaceutical Inc., Ethicon Inc.). In an early communication report on its website, the FDA urged physicians to weigh the potential risks and benefits of using Regranex in each individual patient because of the known risks of diabetic foot and leg ulcers that do not heal.

Researchers evaluated patients with diabetes from a health insurance plan database from January 1998 to June 2003. Patients were at least 19 years of age and had no history of cancer. They found that patients prescribed Regranex three or more times demonstrated an increase in death as a result of cancer, compared with patients who were not prescribed Regranex. No single type of cancer was indicated. At this time, the study did not provide enough evidence to indicate whether the number of patients with new cancers also increased.

After Regranex was approved in 1997, the manufacturer continued to follow studies conducted beforehand to monitor for evidence of adverse events, because of the nature of recombinant human platelet growth factor. A long-term safety study in 2001 revealed more cancers in people who used Regranex vs. those who did not, according to the FDA communication report.