The Food and Drug Administration is strengthening its warning about fluoroquinolones, a class of antibiotics that includes Levaquin, Cipro, Avelox, and Factive. The agency says they shouldn’t be used to treat simple sinus infections, bronchitis and uncomplicated urinary tract infections.
Fluoroquinolones are effective in treating serious bacterial infections. But, the FDA says they come with the potential of disabling side effects involving tendons, muscles, joints, nerves and the central nervous system. These side effects can occur hours to weeks after exposure to fluoroquinolones and may potentially be permanent.
“Fluoroquinolones have risks and benefits that should be considered very carefully,” say Edward Cox, M.D., in the FDA’s Center for Drug Evaluation and Research.
Save fluoroquinolones for toughest infections
The FDA is recommending that this class of antibiotics be reserved to treat only the most serious of bacterial infections — things like anthrax, plague and bacterial pneumonia. For these, says the FDA, there is no alternative treatment and the benefits outweigh the risks.
The FDA is making this clear in a change to the label for all fluoroquinolones. The label must warn of the risk of disabling and potentially irreversible adverse reactions that can occur together. The label must also contain new limitation-of-use statements to reserve fluoroquinolones for patients who do not have other available treatment options for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and uncomplicated urinary tract infections.
According to the Merck Manuel, which provides drug information to doctors, “many newer fluoroquinolones have been withdrawn because of toxicity; they include trovafloxacin (because of severe hepatic toxicity), gatifloxacin (because of hypoglycemia and hyperglycemia), grepafloxacin (because of cardiac toxicity), temafloxacin (because of acute renal failure, hepatotoxicity, hemolytic anemia, coagulopathy, and hypoglycemia), and lomefloxacin, sparfloxacin, and enoxacin.