Fluoroquinolones get tougher FDA warning

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According to the Merck Manuel, which provides drug information to doctors, “many newer fluoroquinolones have been withdrawn because of toxicity; they include trovafloxacin (because of severe hepatic toxicity), gatifloxacin (because of hypoglycemia and hyperglycemia), grepafloxacin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.



About the Author

Ed Tobias
Ed Tobias brings more than four decades of reporting and news management experience to his work at FairfaxNews. Tobias managed news coverage for Associated Press Radio for over twenty years.  This included coverage of the 9/11 attacks, the Iraq War, Hurricane Katrina, the death of Princess Diana, the Challenger and Columbia shuttle disasters and national election primaries, conventions and campaigns.  He was part of the team that built AP’s on-line video operation. Prior to joining AP, Tobias was News Director at all-news WTOP in Washington, D.C. He has won two Ohio State Awards for his reporting and producing and he led coverage that won an Edward R. Murrow Award.