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Jeff Rasansky
Jeff Rasansky
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FDA Announces Label Change Indicating Regranex Risk

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The U.S. Food and Drug Administration (FDA) has announced a boxed warning on the label of Regranex Gel (becaplermin) to address the increased risk of cancer deaths in patients who use 3 or more tubes of the product. Regranex is used for the treatment of leg and foot ulcers that are not healing correctly or at all in diabetic patients.

Ragranex is applied directly to diabetic foot and leg ulcers that aren’t healing. In a study completed in 2001, there were more deaths from cancer in people who used Ragranex than those who didn’t.

In this particular case, the drug manufacturer was aware of the potential cancer hazard in their product, and chose to monitor it closely prior to release. It is alarming to examine just how many drugs are out there whose side effects are potentially harmful or deadly. We have had several clients who ended up with severe adverse effects in using dangerous pharmaceuticals.Click here to learn more about drug injury and the legal process.