FDA Studying Diabetes Gel Regranex

FDA Reviews Study on Cancer Death Risk in Patients Who Repeatedly Use Regranex to Treat Foot and Leg Ulcers

By Miranda Hitti
WebMD Health News

Reviewed By Louise Chang, MD

March 28, 2008 — The FDA is reviewing a possible increased risk of cancer death in diabetes patients who repeatedly use the prescription gel Regranex to treat ulcers on their feet and legs.

The FDA's investigation is still under way, so the FDA hasn't yet concluded whether Regranex has any link to cancer deaths, and the FDA isn't telling doctors to stop prescribing Regranex.

"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.

MedWatch reports can be filed the following ways:

  • On the FDA's web site
  • 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."

SOURCES: News release, FDA. Barbara Montresor, spokeswoman, Ethicon Inc.

© 2008 WebMD Inc. All rights reserved.


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