Regranex, approved for U.S. patients in 1997, is a human-platelet-derived growth factor, a substance naturally produced by the body that helps in wound healing. It works by bringing the cells that the body uses to repair wounds to the site of the ulcer.
Regranex gel must be applied for a few weeks (up to 20 weeks) before ulcers begin to heal, and is used in combination with a good ulcer care program (cleaning, pressure relief, and infection control).
Barbara Montresor, a spokeswoman for Johnson & Johnson's Ethicon Inc unit that makes the gel, said the company was working with the FDA and that Regranex is safe when used as directed.Growth factors cause cells to divide more rapidly and for this reason the manufacturer continued to monitor studies begun before Regranex was approved. A long term safety study completed in 2001 found that there were more cancers in people who used Regranex than in those who did not use the drug. Following the report, an additional study was performed using a health insurance database that covered the period from January, 1998 through June, 2003. The results of this study 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.
In Thursday's announcement, the FDA recommended that while the review is ongoing, endocrinologists, other healthcare professionals, and patients discuss the potential risks and benefits of using Regranex. The FDA added that "because there are known risks associated with diabetic foot and leg ulcers that do not heal, the potential risk of using Regranex should be weighed against the benefit for each individual patient."
As soon as the safety review of Regranex is completed, the FDA will communicate the conclusions and recommendations to the public. In the meantime, healthcare professionals are urged to promptly report serious and unexpected adverse reactions associated with Regranex to the FDA MedWatch reporting program.
By Jaime Jofre