FDA: Johnson & Johnson’s Gel for Diabetic Foot Ulcers Could Heighten Cancer Risk
Posted: Sunday, June 08, 2008
by Avis Ward
GeoVi's Home for Pregnant Teens
If you have diabetes, you are at risk for having a diabetic foot wound. The medical term for diabetic foot wound is diabetic foot ulcer.
Regranex (pronounced ree-gran-x) Gel is a prescription drug for the treatment of deep neuropathic diabetic foot ulcers. Regranex Gel is the only FDA-approved prescription medicine that contains a growth factor that helps your body heal. It is a "man-made version of a substance produced by the human body that helps heal ulcers."
The new boxed warning states that "patients who used three or more tubes of Regranex over a 20-month period were five times more likely to die of cancer." This is a very serious warning.
Diabetes sufferers could perhaps benefit from the information found on J & J's subsidiary's website for Regranex. It has to be important to first:
Understand Diabetic Foot Ulcers – knowledge is power and a clear understanding of the risks associated with developing foot ulcers with this disease can lead to . . .
Preventing Diabetic Foot Ulcers – an ounce of prevention is worth a pound of cure.
- Foot self-exam
- Foot health diary
- Choosing footwear
- Lifestyle habits
Patients are usually told the benefits associated with prescription medications must outweigh the risks before it's prescribed. The report stated that when patients used lower amounts of the cream, the FDA said their chances of developing cancer were no higher than patients who had never used the drug. The new label, which is outlined in a black box, advises doctors to use caution when prescribing the drug to patients with malignancies.
"The findings come from a long-term analysis of records from healthcare providers comparing 1,600 patients who took Regranex with 2,700 patients who did not," according to the FDA.
Johnson & Johnson is said to be cooperating with the FDA on the new label and is "committed to getting the information out to physicians and patients." Regranex is marketed by Ethicon Inc., a subsidiary of Johnson & Johnson.
Avis Ward of AWard Company, LLC
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