Submitted by Armen Hareyan on Jun 6th, 2008
Ethicon added cancer related warning to Regranex adding an Important Safety Information do its diabetes foot ulcer treatment gel.
"REGRANEX Gel should not be used in patients with cancers at the site of application. In a safety study, patients treated with 3 or more tubes of REGRANEX Gel had an increased risk of death from cancer at locations in the body other than the ulcer. Talk to your doctor about risks of cancer and tell your doctor if you have or have had cancer.
"In clinical studies, a small percentage of patients treated with REGRANEX Gel or placebo gel experienced rash near the wound. REGRANEX Gel should not be used by patients sensitive to any components of this product. Please click here to see the Full Prescribing Information for REGRANEX Gel."
REGRANEX Gel is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.
This is the Important Safety Information about REgranex from its earlier press release published on January 23, 2006. As you can read there is no word about cancer risk then.
From earlier official release:
REGRANEX Gel is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply. When used as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control, REGRANEX Gel increases the incidence of complete healing of diabetic ulcers.
The efficacy of REGRANEX Gel has not been established for treatment of pressure ulcers and venous stasis ulcers (see Clinical Studies), and has not been evaluated for the treatment of diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue (Stage I or II, IAET staging classification) or ischemic diabetic ulcers.
Source:
eMaxHealth 