The FDA will ask Regranex maker Ethicon (a division of Johnson & Johnson) to put a "black box" warning label on the drug. The black-box warning is FDA's highest warning level.
"In announcing this label change, FDA still cautions health care professionals to carefully weigh the risks and benefits of treating patients with Regranex," Susan Walker, MD, director of the FDA's Division of Dermatological and Dental Products, says in a news release. "Regranex is not recommended for patients with known malignancies."
"FDA has now completed its review of the study and has concluded that the increase in the risk of death from cancer in patients who used three or more tubes of Regranex was five times higher than in those patients who did not use Regranex," the FDA reports.
Despite this fivefold increase in risk, the finding is based on only four excess cases of cancer, according to an Ethicon news release.
"We remain committed to the safety and efficacy of this product when used according to its label," Ethicon spokeswoman Jackie Jankewicz tells WebMD.
Regranex is a medicine that is a genetically engineered form of a human growth factor that helps wounds heal faster. It is a huge benefit to diabetic patients with slow-healing wounds on their legs or feet that often result in amputation of the affected limb.
Because Regranex makes cells grow faster, there has been concern that it will also make cancer cells grow more quickly. That's why Ethicon has monitored patients since the drug was approved in December 1997.
There's no evidence that Regranex causes new cancers, although the follow-up study has not gone on long enough to rule out this possibility.