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Cancer Research Journal Article

FDA to Diabetics: Regranex Foot Cream Raises Cancer Risk

The is warning doctors and the public that who use a few tubes of the foot cream () are significantly increasing their risk of .

REGRANEX™ is a topical gel cream to treat in people with . The product contains recombinant human platelet-derived growth factor, a man-made substance that stimulates cell growth. The medicine is designed to help heal ulcers which, if serious enough, can ultimately lead to .

REGRANEX™ has been prescribed more than 750,000 times since it became available.

The new warnings were issued after a retroactive epidemiological study of more than 4,400 patients showed those prescribed three or more tubes of REGRANEX™ were 5 times more likely to die of .

As a result of the study’s findings, the FDA advises physicians to only prescribe the drug when the benefits to the patient outweigh the potential risks and to exercise extra caution when prescribing REGRANEX™/becaplermin to individuals who’ve already been diagnosed with a malignancy.

A boxed warning is also being added to the product’s packaging. It reads,

“WARNING
An increased risk of mortality secondary to malignancy was observed in patients treated with 3 or more tubes of REGRANEX Gel in a post-marketing retrospective cohort study. REGRANEX Gel should only be used when the benefits can be expected to outweigh the risks. REGRANEX should be used with caution in patients with known malignancy.”

Boxed Warning for REGRANEX™
Issued by FDA, June 2008

REGRANEX™ is marketed by , a subsidiary of (). The drug is distributed by .

Tumors or other adverse events associated with REGRANEX™/becaplermin should be reported to the FDA MedWatch Adverse Event Reporting Program (telephone 1-800-FDA-1088 or online at www.fda.gov/MedWatch/report.htm).

If you’d like other information about Regranex, you can call the company’s Customer Communications Center at 1-888-734-7263.

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Published by Lisa on Saturday 7 June 2008 at 2:16 pm - permalink
Filed under General Cancer Info,Government,Products

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