July 8, 2008

Warnings Ordered for Some Antimicrobials

The U.S. Food and Drug Administration says it's notified makers of fluoroquinolone antimicrobial drugs that a boxed warning is necessary for those products.

The FDA said it is also requiring those manufacturers to provide a medication guide to patients about the increased risk of tendinitis and tendon rupture.

Fluoroquinolones are effective in treating certain bacterial infections but 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 Dr. Edward Cox, director of the FDA's Office of Antimicrobial Products.

The federal agency said 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.

The FDA said medications involved in the action are: Cipro and generic ciprofloxacin, Cipro XR and Proquin XR, Factive (gemifloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin) and Floxin and generic ofloxacin.