Boxed warning added to Regranex prescribing information

June 10, 2008

Increased risk of cancer mortality found with Ethicon's diabetic foot ulcer cream.

The Food & Drug Administration has announced the addition of a boxed warning to the prescribing information for becaplermin (Regranex gel 0.01%, Ethicon) following data from a retrospective study that showed a five-fold increased risk of cancer mortality in patients who used three or more tubes of the product. Becaplermin is a recombinant human platelet-derived growth factor indicated as an adjunct to the treatment of lower extremity diabetic neuropathic ulcers. The data did not identify any specific type of cancer. In March 2008, the FDA issued an Ongoing Safety Review Communication on the product, promising a safety review of becaplermin and follow-up communication. The agency cautions healthcare professionals not to use the product in patients with known malignancies.

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