"At this time, FDA believes that there may be some evidence for an increased risk of death from cancer in patients who had repeated treatments with Regranex," an FDA news release states. "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 potential benefit for each individual patient."
Regranex is a medicine that contains a recombinant form of human platelet-derived growth factor. It's applied directly to diabetic foot and leg ulcers that aren't healing. Growth factors make cells divide faster.
Ethicon Inc., the Johnson & Johnson company that makes Regranex, has continued to monitor Regranex studies begun before the drug's 1997 approval.
In a long-term safety study completed in 2001, there were more cancers in people who used Regranex than in those who didn't use Regranex.
In another study, researchers used a health insurance database to study two similar groups of patients, some of whom used Regranex. The study's results showed a higher rate of cancer deaths among patients who got three or more prescriptions for Regranex than those not treated with Regranex. No single type of cancer stood out, according to the FDA.
The FDA urges health care professionals to promptly report serious and unexpected adverse reactions associated with Regranex to the FDA MedWatch reporting program.
By returning the postage-paid FDA form 3500 to 5600 Fishers Lane, Rockville, MD 20852-9787
Faxing the form to 800-FDA-0178
By phone at 800-332-1088
"We will continue to work closely with the FDA as it conducts its ongoing safety review of Regranex gel," Ethicon spokeswoman Barbara Montresor tells WebMD via email. "Our first concern, as always, is for the safety of our patients. We are confident in the safety and efficacy of Regranex when used according to its label."