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Regranex Cream linked to increased risk of death from cancer 6-7-08

The Food and Drug Administration released today an update on the ongoing Safety Review of Regranex or becaplermin saying it has concluded that "the increase in the risk of death from cancer in patients who used three or more tubes of Regranex was five times higher than in those patients who did not use Regranex."

This update is a follow-up to the March 27, 2008 communication released by the FDA, which states 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."

In today's update, the FDA says, however, that the risk of getting new cancers among Regranex users was the same as that among non-users. The agency cautions that this drug is not definitely risk free. The fact is that the study is not long enough to determine whether this drug raises cancer risk or not.

In response to the FDA conclusion, Johnson & Johnson, the manufacturer of Regranex, has added this information and a strong Boxed Warning to the labeling for the products.

Regranex gel is used to heal diabetic foot ulcers which are the leading causes for hospitalization of patients with diabetes. With good ulcer care, the drug increases the chance for the patients to completely overcome the condition.

Because of the potential risk, the FDA recommends that Regranex be only used when the benefits are expected to outweigh the risks.

Johnson & Johnson's Ethicon unit, which sells Regranex, suggested the risk is minimal if there is any by saying that only four cases of cancer among patients who used three or more tubes of the product were reported while in the past ten years, more than 750,000 patients have used the product.

"We remain confident in the safety and efficacy of Regranex Gel when used according to its label," James Hart, Ethicon's vice president for global medical affairs, was quoted by Reuters as saying in a statement.

Comment:

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