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Regranex (becaplermin) Gel

June 6, 2008

Audience: Endocrinologists, other healthcare professionals, patients

[UPDATE 06/06/2008] FDA informed healthcare professionals that a Boxed Warning was added to prescribing information for Regranex that describes an increased risk of death from cancer in patients treated with three or more tubes of Regranex compared with those patients who did not use the product. FDA recommends that Regranex be used only when the benefits can be expected to outweigh the risks.

[Posted 03/27/2008] The FDA is conducting a safety review based on study data suggesting there may be an increased risk of death from cancer in diabetic patients using Regranex (becaplermin) Gel, a skin product used to heal leg and foot ulcers. While the review is ongoing, the FDA recommends health care professionals discuss the potential risks and benefits of using Regranex with their patients.

This communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.

[March 27, 2008 - Communication About an Ongoing Safety Review - FDA]

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