The FDA ( Food and Drug Administration ) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary.
Fluoroquinolones are drugs approved for the treatment or prevention of certain bacterial infections.
The FDA has conducted a new analysis of the available literature and post-marketing adverse event reports. This new analysis reconfirms 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 labeling for the fluoroquinolones, large numbers of tendon-related adverse events continue to be reported.
The FDA also issued Information for Health Care Professionals today to alert health care professionals to the increased risk of tendinitis and tendon rupture in patients taking these drugs and to highlight new information concerning who may be at higher risk for this side effect.
The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in people older than 60, in those taking corticosteroid drugs, and in kidney, heart, and lung transplant recipients.
Patients experiencing pain, swelling, inflammation of a tendon or tendon rupture should be advised to stop taking their fluoroquinolone medication and to contact their health care professional promptly about changing their antimicrobial therapy.
Patients should also avoid exercise.
Manufacturers are being notified of the need to change labeling so that all of the drugs in the class carry uniform updated warning language. These warnings would apply to fluoroquinolones for systemic use. The warnings would not apply to fluoroquinolones for topical ophthalmic or otic use.
The medications involved in this action are: Cipro and generic Ciprofloxacin, Cipro XR and Proquin XR ( Ciprofloxacin extended release ), Factive ( Gemifloxacin ), Levaquin ( Levofloxacin ), Avelox ( Moxifloxacin ), Noroxin ( Norfloxacin ), and Floxin and generic Ofloxacin.
Source: FDA, 2008
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