FDAnews Drug Daily Bulletin

FDA Requires Label Update for Fluoroquinolone With New Safety Information

May 19, 2016

The FDA is requiring drug labels and medication guides be updated for all fluoroquinolone antibacterial drugs due to new safety information that indicates its risks outweigh the benefits.

A safety review showed that systemic use of fluoroquinolone is associated with potentially permanent adverse effects involving the tendons, muscles, joints, nerves and central system.

Current FDA-approved fluoroquinolone antibacterial drugs include: Avelox, Cipro, Cipro extended-release, Factive, Levaquin, Moxifloxacin Injection and Ofloxacin.


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