WEST PALM BEACH, Fla. (Cox News Service) -- The Food and Drug Administration should strongly warn the public about the risk of tendon rupture associated with Cipro and other fluoroquinolone antibiotics, Public Citizen said in a petition to the agency.
The public-interest watchdog organization joined with Illinois Attorney General Lisa Madigan's office, which also sent the FDA an addendum to its earlier petition urging the agency to act.
"The numbers are startling. Tendon ruptures associated with these drugs continue to occur at a disturbing rate but could be prevented if doctors and patients were more aware of early warning signals, such as the onset of tendon pain, and switched to other antibiotics," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. "The FDA must act and require black box warnings and patient information guides."
Public Citizen's review of the FDA's adverse event database shows 262 reported cases of tendon ruptures, 258 cases of tendonitis and 274 cases of other tendon disorders between November 1997 and Dec. 31, 2005, associated with the fluoroquinolone antibiotics, with 175 of those occurring since the beginning of 2003.
Sixty-one percent of the ruptures were associated with Levaquin, which has accounted for 45 percent of all fluoroquinolone prescriptions in the past four years; 23 percent of the ruptures were associated with Cipro.
One theory is that fluoroquinolones are toxic to tendon fibers and might decrease blood supply in tendons that already have a limited blood supply.
Antibiotics which are widely prescribed for gastrointestinal, respiratory and genito urinary tract infections, include Cipro (Ciprofloxacin, made by Bayer), Penetrex (Enoxacin, made by Aventis), Tequin (Gatifloxacin, made by Bristol-Myers Squibb), Levaquin (Levofloxacin, made by Ortho-McNeil), Maxaquin (Lomefloxacin, made by Unimed), Avelox (Moxifloxacin, made by Bayer), Noroxin (Norfloxacin, made by Merck) and Floxin (Ofloxacin, made by Daiichi-Sankyo).
Copyright 2006 The Cox News Service. All rights reserved.
|
