Regranex’s New Black Box Warning

The FDA has moved to have Ethicon the maker of Regranex put a “black box” warning on the label.  The “black box” is the highest FDA warning level.  Regranex gel is used to treat dangerous foot and leg ulcers in diabetics.  Regranex is a medicine that is a genetically engineered form of a human growth factor that helps wounds heal faster. It is a huge benefit to diabetic patients with slow-healing wounds on their legs or feet that often result in amputation of the affected limb.

But its effect on human growth factor may make cancer cells grow quicker too. Post marketing studies showed patients may have a fivefold higher risk of dying from cancer.

“In announcing this label change, FDA still cautions health care professionals to carefully weigh the risks and benefits of treating patients with Regranex,” Susan Walker, MD, director of the FDA’s Division of Dermatological and Dental Products, says in a news release. “Regranex is not recommended for patients with known malignancies.”

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