FDA to Diabetics: Regranex Foot Cream Raises Cancer Risk
The US Food and Drug Administration is warning doctors and the public that diabetics who use a few tubes of the foot cream REGRANEX™ (becaplermin) are significantly increasing their risk of cancer-related death.
REGRANEX™ is a topical gel cream prescribed to treat leg and foot ulcers in people with diabetes. The product contains recombinant human platelet-derived growth factor, a man-made substance that stimulates cell growth. The medicine is designed to help heal neuropathic ulcers which, if serious enough, can ultimately lead to amputation.
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 cancer.
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 Ethicon©, Inc, a subsidiary of Johnson & Johnson (NYSE: JNJ). The drug is distributed by Ortho-McNeil™.
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.
Source: FDA Center for Drug Evaluation and Research
Related Links: FDA News; CNNMoney
Technorati Tags: cancer prevention; comorbidity; drug safety; oncology; pharmacology; patient safety; tumor reporting
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