Black Box Warning Added to Regranex® Gel

            The FDA announced on June 6, 2008 that a black box warning was added to the prescribing information for Regranex (becaplermin) gel.  The warning outlines the increased risk of death secondary to malignancy seen in a post-marketing retrospective study.  The study showed that patients treated with 3 or more tubes of Regranex where five times more likely to die from cancer than patients who did not use the product.  The warning requirement stemmed from a safety review conducted by the FDA based on this study data.  The risk of developing new cancers among patients using Regranex was not increased compared to those who did not use the product.  However, the duration of follow-up in the study was not long enough to detect new cancers.

            Regranex is indicated for the treatment of adult diabetic skin ulcers.  It is classified as a platelet derived growth factor and was approved by the FDA in 1997.  Through formation of granulation tissue in diabetic ulcers, Regranex promotes healing via chemotatic recruitment and proliferation of cells that are involved in wound repair.  When used in conjunction with proper ulcer care, Regranex can increase the chances of complete ulcer healing.  However, the FDA recommends that it should only be used when the benefits outweigh the risks associated.  The FDA also encourages medical professionals as well as patients to report any adverse events that are thought to be associated with the use of this product via the MedWatch program. 

References:

1.  www.fda.gov
2.  Micromedex Database

Chris Costelnock, PharmD. Candidate