The U.S. watchdog the Food and Drug Administration (FDA) says a warning will be added to the label of a topical gel used to treat leg and foot ulcers which refuse to heal in diabetic patients.
The warning will be added to the labels of Regranex Gel 0.01% (becaplermin) advising of an increased risk of death from cancer.
It seems patients who use 3 or more tubes of the product expose themselves to a five-fold increased risk of death from some form of cancer.
The warning on the product follows the release of data from a retrospective study that compared cancer incidence and cancer mortality among 1,622 patients exposed to Regranex, to 2,809 otherwise similar patients who were not exposed.
The results were consistent with no overall increase in cancer incidence among the patients exposed to Regranex but those who had used three or more tubes of Regranex increased their risk of death from cancer by five times.
The FDA says caution must be used by doctors before prescribing Regranex and the risks and benefits carefully considered.
The FDA says Regranex is not recommended for patients with known malignancies.
Regranex is a drug which is a recombinant form of human platelet-derived growth factor - it is applied directly to diabetic foot and leg ulcers which are not healing and has a biologic activity that causes cells to divide more rapidly.
Regranex was approved in December 1997 and a long term safety study completed in 2001, found there were more deaths from cancer in people who used Regranex than in those who did not use it.
This prompted an additional study which 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 specific type of cancer was identified, but rather deaths from all types of cancer, combined were observed.
The FDA recommends that Regranex be used only when the benefits can be expected to outweigh the risks.