Excess Cancer Deaths Prompt FDA Review of Becaplermin Gel Safety

By John Gever
ROCKVILLE, Md., March 27 -- The FDA said today it was reviewing the safety of becaplermin gel (Regranex) after learning it may increase cancer deaths in patients with diabetes.
The agency identified no single type of cancer from use of the topical form of recombinant platelet-derived growth factor, which is indicated for healing of persistent diabetic leg and foot ulcers.
It said only that a study of insurance plan data showed that deaths from all types of cancer combined were increased.
While the review is underway, the FDA recommended that physicians discuss the potential risks and benefits of the drug with their patients. The agency noted that non-healing ulcers also carry risks for the patient.
The agency said the study found that deaths from cancer were higher for patients given three or more becaplermin prescriptions compared with similar patients not treated with the drug.
There was not enough information to say whether there was an increase in the number of patients who developed new cancers, according to the FDA.
The agency said an earlier study completed in 2001 had found more cancers in patients using becaplermin compared with those not using it, prompting the follow-up analysis of insurance plan data.