WASHINGTON (Reuters) - Johnson & Johnson has added a strong "black box" warning about the risk of dying from cancer to the prescribing instructions for the company's Regranex diabetic foot gel, U.S. regulators said on Friday.
A study showed the chances of dying from cancer were five times higher for patients who used three or more tubes of Regranex when compared with others who did not use the product, the Food and Drug Administration said.
No increase in cancer cases was found in the overall group that included patients prescribed smaller amounts of the drug, the FDA said. The agency noted, however, that the study was too short to detect new cases.
"Regranex is not recommended for patients with known malignancies," Dr. Susan Walker, director of the FDA's division of dermatological and dental products, said in a statement.
The study compared data among 1,622 patients exposed to Regranex and 2,809 similar patients who were not treated with the product, which is applied to diabetic foot and leg ulcers.
Johnson & Johnson's Ethicon unit, which sells Regranex, said the new warning was based on four cases of cancer among patients who used three or more tubes of the product.
Regranex has been sold for 10 years and used by more than 750,000 patients, Ethicon said.
"We remain confident in the safety and efficacy of Regranex Gel when used according to its label," James Hart, Ethicon's vice president for global medical affairs, said in a statement.
Regranex, known generically as becaplermin, is a synthetic form of a human growth factor. Because growth factors cause cells to divide more rapidly, the manufacturer monitored cancer cases before and after the product's approval, the FDA said.
The FDA announced in March it was reviewing a possible link between Regranex and cancer.
