FDA issues updated fluoroquinolone warning labels

August 11th, 2016

The U.S. Food and Drug Administration announced an update to fluoroquinolone warning labels, enhancing their warning about risks of serious FLQ side effects. The FDA also aims to reduce the use of the powerful antibiotics to only patients with certain serious infections.

The warning label change has been a long time coming. FLQ antibiotics such as Levaquin, Avelox and Cipro are among the most-prescribed medications and carry increased risks of serious conditions, including tendon rupture and damage.

Many doctors have also expressed concerns that FLQs are overprescribed. The powerful antibiotics have been given to treat a wide range of infections. The FDA chose to limit their recommended use among patients suffering from acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and uncomplicated urinary tract infections. The FDA says patients with these conditions should only seek treatment from FLQs if no other options are available.

The warning labels now include information about FLQ side effects with potentially debilitating consequences. The drugs have been found to cause serious damage to muscles, tendons, joints, nerves and the central nervous system. Patients who were given FLQs and suffered serious side effects have begun filing antibiotic lawsuits alleging that the drug’s manufacturers failed to warn doctors and patients of the increased risk of complications associated with the drugs.


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