Foot Ulcer Treatment Linked to Death from Cancer

The prescription gel becaplermin (brand name Regranex), which is used to treat foot ulcers and leg ulcers, is being investigated for a possible link to increased cancer risk in people with diabetes.

In a news release last month, the U.S. Food and Drug Administration (FDA) announced that “there may be some evidence for an increased risk of death from cancer in patients who had repeated treatments with Regranex.” The organization is conducting a safety review of the drug. It is not currently telling doctors to stop prescribing Regranex; instead, it says that the benefits of the drug in helping heal ulcers should be weighed against its risks for each individual patient.

Regranex was approved by the FDA in 1997. In 2001, a long-term study showed a higher rate of cancer in people who used Regranex compared to those who didn’t. Now, a new study examining a health insurance database has compared two groups of adults with diabetes, one of which used Regranex and one of which did not. Neither group had a history of cancer, and the two had similar histories of diagnoses, medicine use, and use of health services. Over a five-year period, the researchers found a higher rate of death from all types of cancer in the people who received three or more prescriptions for Regranex compared to those who did not use the drug. Whether there was a higher rate of new cancer development in the people who used Regranex wasn’t clear from the data.

Regranex, a gel that is applied directly to foot and leg ulcers that aren’t healing, contains a recombinant form of human platelet-derived growth factor. The substance helps heal ulcers by stimulating cells to divide more rapidly; however, this action may also increase cancer risk.

The FDA has asked health-care professionals to report any “serious and unexpected adverse reactions associated with Regranex” to the FDA MedWatch reporting program. Reports can be filed online at www.fda.gov/medwatch/report.htm, by phone at (800) 332-1088, or by mailing form 3500, found here, to 5600 Fishers Lane, Rockville, MD, 20852-9787. The form can also be faxed to (800) FDA-0178.