To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Powerful Nonnarcotic Analgesic Cleared By FDA URL: http://www.pslgroup.com/dg/2F432.htm Doctor's Guide July 16, 1997
PHILADELPHIA, PA -- July 16, 1997 -- Duract(TM) (bromfenac sodium capsules), a potent nonnarcotic analgesic that belongs to the nonsteroidal anti-inflammatory drug (NSAID) class, was cleared for marketing yesterdayby the U.S. Food and Drug Administration (FDA), said Wyeth-Ayerst Laboratories, a division of American Home Products Corporation, announced today. The availability of Duract(TM) marks an important development for health care providers whose patients need fast-acting and powerful relief from acute pain, but want to avoid many of the performance-impairing side effects that can accompany a narcotic opioid analgesic. "This new medication should be a welcome relief for people whose activities have been compromised by acute pain," says Marc W. Deitch, M.D., Senior Vice President, Medical Affairs and Medical Director for Wyeth-Ayerst Laboratories. "Duract(TM) (bromfenac sodium capsules) can provide pain sufferers significant relief from their pain without the combined worry of opioid side effects and the potential for chemical dependency." Today's FDA marketing clearance follows a series of clinical studies that demonstrate the effectiveness of Duract in the management of acute pain in a wide range of applications, such as postoperative use following major abdominal, gynecologic, oral, or orthopedic surgery. The most frequent complaints with Duract(TM) use relate to minor gastrointestinal problems. In some patients treated with Duract, serious gastrointestinal toxicity such as perforation, ulceration, and bleeding can occur. In addition, elevations of liver enzymes have been reported. Therefore, while Duract(TM) is indicated for the short-term management of pain, generally less than 10 days duration, if a physician chooses to administer Duract for a longer duration, it is recommended that liver enzymes should be monitored in patients treated for more than four weeks. More information on: Wyeth-Ayerst Laboratories, More information on: American Home Products Corporation --------------------------------------------------------------------------------------------- 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.