U.S. FDA Removes Safety Warning From Smith & Nephew's Diabetic Gel

December 5, 2018

By Reuters Staff

(Reuters) - British medical products maker Smith & Nephew said on Wednesday that the U.S. Food and Drug Administration (FDA) had approved the removal of a safety warning on its treatment for lower extremity diabetic neuropathic ulcers.

The label on the box of the Regranex gel (becaplermin) since 2008 warned of "increased rate of mortality secondary to malignancy" after an initial study, the company said.

The company had petitioned for removal of the warning and the FDA's latest decision followed multiple studies that demonstrated no increased safety risk from the gel, Smith & Nephew said.

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