To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Becaplermin May Increase Risk of Death From Cancer in Patients With Diabetes URL: http://www.pslgroup.com/dg/21ED46.htm Doctor's Guide March 27, 2008
WASHINGTON, DC -- March 27, 2008 -- The US Food and Drug Administration is conducting a safety review based on study data suggesting there may be an increased risk of death from cancer in diabetic patients using becaplermin (Regranex Gel), a skin product used to heal leg and foot ulcers. In a long-term safety study completed in 2001, there were more cancers in people who used becaplermin than in those who did not use it. Following the report of this study, an additional study was performed using a health insurance database that covered the period from January 1998 through June 2003. This study used the database to identify 2 groups of patients with similar diagnoses, drug use, and use of health services, one of which used becaplermin and one group that did not. The results of this study showed that deaths from cancer were higher for patients who were given 3 or more prescriptions for treatment with becaplermin compared with those who were not treated with the agent. No single type of cancer was identified, but rather deaths from all types of cancer combined were observed. While the review is ongoing, the FDA recommends that healthcare professionals discuss the potential risks and benefits of using becaplermin with their patients. SOURCE: US Food and Drug Administration --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.