FDA asks to place “black box” warning on Regranex after cancer is linked to drug

The Seattle Post-Intelligencer reports that the Food and Drug Administration has asked Johnson & Johnson to place a “black box” warning on their foot and leg ulcer cream, Regranex, after studies show that people who used three or more tubes of the product have a five-fold risk of cancer and death.

A “black box” warning is the FDA’s highest warning level. In issuing the warning, the FDA does not advise health care professionals to discontinue prescribing the product, but they advise physicians to weight the benefits against the risks for each patient.

Regranex is manufactured by Ethicon, a division of Johnson & Johnson. Regranex gel is prescribed to treat dangerous foot and leg ulcers in patients who have diabetes.

Approximately 750,000 people have been prescribed Regranex since it was approved by the RDA in 1997.

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