FDA launches safety review of J&J's Regranex

The US Food and Drug Administration has launched a safety review after receiving study data that showed an increased risk of cancer in patients with diabetes who applied Johnson & Johnson's topical growth factor Regranex directly to their foot and leg ulcers.

The evaluation was done using a health insurance plan database of patients with diabetes who were at least 19 years of age or older, with no history of cancer and either prescribed Regranex or not. In this study, among those prescribed the agent three or more times, there was an increase in the number of patients who died as a result of cancer There was not enough information to say whether there was an increase in the number of patients that developed new cancers, the agency noted. At this time, the FDA believes that there may be some evidence for an increased risk of death from cancer in patients who had repeated treatments with the J&J drug. The recombinant platelet-derived growth factor-based product was first approved in the USA in 1997 and has also been registered in Europe, and other countries including Canada, Argentina, Brazil, Israel, Mexico and Singapore.