“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.” 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.
Regranex Gel has been linked to a substantially increased risk of death from cancer when three or more tubes are used within 20 months to treat severe foot or leg ulcers in diabetics. In June 2008, the FDA announced a “black box” warning about the risk of cancer death as a possible side effect of Regranex.
STATUS OF REGRANEX LAWSUITS: Potential cases are being reviewed by lawyers on behalf of individuals who died from cancer after using three or more tubes of Regranex Gel
I have stage 3 breast cancer, and I was treated with Regranex and STILL had a toe amputated. not only did this crap not do what it was supposed to do, now it probably has caused the cancer that will kill me. Perhaps the drug companies someday will put people’s lives before PROFITS (but probably NOT in MY lifetime)*****>
"Regranex Topical Gel - first FDA-approved advanced care biologic topical agent for the treatment of patients with lower extremity neuropathic diabetic foot ulcers.
Excellagen just approved by FDA is a highly purified, physiologically formulated fibrillar bovine Type I collagen-based topical gel (2.6% collagen) designed to support favorable wound care management. There are no other collagen-based wound care management dressings available for professional use in the United States that are considered comparable to Excellagen in terms of its overall formulation, fibrillar nature, and product format. Other professional-use collagen-based products include granulated collagens that require mixing prior to use, as well as a variety of sheet-based products.
Regranex is patient administered, requires daily application followed by a daily cleansing 12 hours after the drug treatment over a 20-week period. As a result, during the prescribed 20-week treatment period, Regranex patients are required to undertake approximately 280 interventions (drug administrations and cleansings) to achieve the potential maximum healing effect.
Excellagen requires one or two physician administered treatment regimen.
Regranex - 50% of patients achieved complete wound closure in 20 weeks.
Excellagen - 83% of patients achieved complete wound closure in 14 weeks.
Regranex - Increase cancer risk in Patients
Excellagen - appears to be both safe and well tolerated, with no serious adverse events attributable to the study product.
The wound care market is projected to experience double digit growth over the next 3 to 5 years, with advanced wound care products comprising the fastest growing segment of the total wound care market. There are an estimated 91.3 million wounds in the U.S., which include 67.0 million surgical wounds, 17.6 million trauma wounds including burn injuries and amputations, 2.5 million pressure ulcers, 3.6 million diabetic ulcers and 3.3 million venous stasis and arterial ulcers. The ability to effectively address even a small proportion of these wounds would represent major new market opportunities for the Company's Excellagen.
In other words Excellagen will be the Number 1 topical gel for wound care which equals..........