FDA Studying Diabetes Gel Regranex
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Dr.Vikram
Apr 8, 2008, 12:30:30 PM4/8/08
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FDA Studying Diabetes Gel Regranex
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 Medical 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.
Vikram
Source: Web MD
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 Medical 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.
Vikram
Source: Web MD
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