FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated
infections; warns about disabling side effects that can occur together
Safety Announcement
[05-12-2016]
"The U.S. Food and Drug Administration is advising that the serious side
effects associated with fluoroquinolone antibacterial drugs generally outweigh the
benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections
who have other treatment options. For patients with these conditions, fluoroquinolone
should be reserved for those who do not have alternative treatment options.
An FDA safety review has shown that fluoroquinolones when used systemically (i.e.
tablets, capsules, and injectable) are associated with disabling and potentially permanent
serious side effects that can occur together. These side effects can involve the tendons,
muscles, joints, nerves, and central nervous system.
As a result, we are requiring the drug labels and Medication Guides for all
fluoroquinolone antibacterial drugs to be updated to reflect this new safety information.
We are continuing to investigate safety issues with fluoroquinolones and will update the
public with additional information if it becomes available..."