Becaplermin (marketed as Regranex) Information

Update (June 6, 2008) — FDA issued a follow-up communication describing changes that were made to the labeling for Regranex following the notice posted on March 27, 2008. A Boxed Warning was added to the labeling advising prescribers and patients that an increased risk of death from cancer was seen in patients treated with three or more tubes of Regranex compared with those patients who did not use Regranex. FDA recommends that Regranex be used only when the benefits can be expected to outweigh the risks.

On March 27, 2008, FDA announced that it had received information about a postmarket epidemiologic study that was performed to investigate the possibility of an increased risk of cancer in patients with diabetes who applied the product Regranex (a topical medicine) directly to their foot and leg ulcers.

• Follow-up to the March 27, 2008, Communication about the Ongoing Safety Review of Regranex (becaplermin) (6/6/2008)
• Communication about an Ongoing Safety Review Regranex (becaplermin) (3/27/2008)
• Dear Healthcare Provider Letter

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Date created: June 6, 2008

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