FDA issues updated label warnings for Levaquin, Cipro antibiotics

Updated 'Black Box' warnings

WASHINGTON D.C. - The U.S. Food and Drug Administration issued updated warnings on Tuesday for some of the most prescribed antibiotics on the market due to disabling and potentially permanent side effects.

The FDA approved safety labeling changes for a class of antibiotics called fluoroquinolones that include popular drugs like Cipro, Levaquin and Avelox.

The enhanced warnings include an updated "Boxed Warning," often called black box warnings and revisions to the warnings and precautions sections.

The updated warnings come in the wake of an exclusive 5 On Your Side investigation in July 2015 that revealed disabling side effects involving tendons, joints and nerve damage.

The updated warnings include alerting patients that "serious side effects generally outweigh the benefits" for patients with acute bacterial sinusitis and uncomplicated urinary tract infections.

The FDA determined that fluoroquinolones should be "reserved for use in patients" who have no alternative treatment options.

Print this article Back to Top