FDA Imposes Urgent Safety Warnings on Fluoroquinolone Drugs Due to Tendon Risks
By Aaron Poehler
Published on July 08, 2008
The U.S. Food and Drug Administration announced today that they will require a class of antibiotic drugs known as fluoroquinolones to carry their most serious warnings on their packaging.
Fluoroquinolones are a group of potent broad-spectrum antibiotics approved for the treatment and prevention of certain bacterial infections. Bayer's Cipro (ciprofloxacin) and Ortho-McNeil's Levaquin (levofloxacin) are the two most prominent examples of fluoroquinolone antibacterials, though fluoroquinolones are marketed under various other brand and generic names including Levaquin, Factive (gemifloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), Floxin, and generic ofloxacin and ciprofloxacin.
The new 'black box' warning labels follow in the wake of a lawsuit filed by consumer group Public Citizen against the FDA to force the agency to warn consumers and doctors of potential tendonitis and tendon rupture risks accompanying use of the drugs. Manufacturers of fluoroquinolone drugs will also be required to provide medication guides for patients and doctors detailing the drugs' possible side effects.
While current fluoroquinolone warning labels do mention the elevated risk of tendon rupture, continued reports of tendon injuries led FDA officials to believe those warnings were not being heeded by enough doctors or patients.
Although the connections between fluoroquinolone use and tendon problems are not clearly understood right now, the FDA's Dr. Renata Albrecht stated that studies have shown that fluoroquinolones can increase the risk of tendonitis and tendon rupture by as much as 400 percent.
Find a defective drugs attorney if you or a loved one has been injured after taking Levaquin, Cipro, or another fluoroquinolone.
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