FDA has restricted fluoroquinolone antibiotic use for sinusitis, bronchitis, and uncomplicated urinary tract infections due to serious side effects


The U.S. Food and Drug Administration ( FDA ) has advised 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, FDA is requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to reflect this new safety information.

FDA is continuing to investigate safety issues with fluoroquinolones and will update the public with additional information if it becomes available.

Patients should contact health care professional immediately if they experience any serious side effects while taking your fluoroquinolone medicine.
Some signs and symptoms of serious side effects include tendon, joint and muscle pain, a pins and needles tingling or pricking sensation, confusion, and hallucinations.

Health care professionals should stop systemic fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course.

List of currently available FDA-approved fluoroquinolone antibacterial drugs for systemic use: Avelox ( Moxifloxacin ), Cipro ( Ciprofloxacin ), Cipro extended-release ( Ciprofloxacin extended-release ), Factive ( Gemifloxacin ), Levaquin ( Levofloxacin ), Ofloxacin ( Ofloxacin ). ( Xagena )

Source: FDA, 2016

XagenaMedicine, 2016



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