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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