Regranex is a drug prescribed to promote healing. It works by encouraging growth of cells that aid in wound healing. This drug is often used to treat foot and leg ulcers in diabetic patients that take longer to heal because of the patient’s condition. Regranex is manufactured by Johnson & Johnsons and was approved by the FDA in 1997. It has been used by more than 750,000 patients.
In 2008, the FDA required that a black box warning be placed on Regranex, warning about serious side effects. In a study completed in 2001, it was found that patients who used Regranex have a higher risk of cancer death than patients who were not exposed to the drug.
Another study completed in 2008 found that patients who had been prescribed Regranex three or more times had an increased risk of cancer deaths as well. In this study, researchers found that this group of patients had a cancer risk that was five times higher than others. Also, of these patients, if the person already had cancer, Regranex was found to increase the risk of cancer death severely.
Doctors have been advised not to prescribe Regranex three times within 20 months to patients and to be very cautious when prescribing the drug to patients who already have cancer.