EMEA recommends Janssen-Cilag's Regranex not be used in patients with any pre-existing cancer

Following a review of the available data on a possible risk of cancer in patients using Regranex (becaplermin), from Janssen-Cilag International (part of US drugs major Johnson & Johnson) the European Medicines Agency (EMEA) has concluded that the drug must not be used in patients who have any form of cancer. A similar restriction previously applied, but only for patients who had a skin cancer close to the area where the gel was to be applied.

Regranex is a gel that is used together with other wound care measures to treat long-term skin ulcers in people with diabetes. Patients using Regranex who have, or have had, cancer should speak to their doctor at their next routine appointment in order to arrange alternative treatment.

The review, conducted by the Agency's Committee for Medicinal Products for Human Use (CHMP), was initiated at the request of the European Commission because of reports of cancer developing in a small number of patients using the gel. In an observational study, that compared Regranex-users with a control group of patients who did not use this product, the overall risk of developing cancer was not found to be significantly different between Regranex-users and non-users. However, patients who used three or more tubes of Regranex and who developed cancer had a greater risk to die of their cancer than those who did not use Regranex. The study had several limitations in its design, including a small number of cases of cancer and is therefore not considered to be robust, the EMEA stated.