To print: Select File and then Print from your browser's menu
---------------------------------------------------------------------------------------
Title: FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs
URL: http://www.pslgroup.com/dg/22549A.htm
Doctor's Guide
July 8, 2008

ROCKVILLE, Md -- July 8, 2008 -- The US Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labelling concerning the increased risk of tendinitis and tendon rupture is necessary.

The FDA has notified the manufacturers of these drugs that a Risk Evaluation and Mitigation Strategy (REMS) is necessary to ensure that the benefits of the drug outweigh the risks and that a Medication Guide for patients is necessary to warn about possible side effects.

"… Healthcare professionals and patients need to be aware of the increased risk associated with the use of these drugs of developing tendinitis and tendon rupture, particularly for certain patient populations," said Edward Cox, MD, Office of Antimicrobial Products, Center for Drug Evaluation and Research.

The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in people aged older than 60 years, in those taking corticosteroid drugs, and in kidney, heart, and lung transplant recipients.

The FDA has conducted a new analysis of the available literature and postmarketing adverse event reports that confirms that use of fluoroquinolones is associated with an increased risk of tendon rupture. It also demonstrates that despite the current warning of tendon rupture in the labelling, large numbers of tendon-related adverse events continue to be reported.

The medications involved in this action are: ciprofloxacin, (Cipro, Cipro XR, ProQuin XR), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin).

For further information on fluoroquinolone antimicrobial drugs, see: http://www.fda.gov/cder/drug/InfoSheets/HCP/fluoroquinolonesHCP.htm


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.