Advise for Restricting Use of Fluoroquinolones in Uncomplicated Systemic Infections

Drug Alerts , News / October 7, 2016

The FDA is advising that the serious side effects associated with use of fluoroquinolone antibacterials generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options available. For such conditions, fluoroquinolones 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.

Fluoroquinolones are a bactericidal class of antimicrobials that act by interfering with nucleic acid synthesis or function in the invading organism. Currently available FDA approved fluoroquinolones for systemic use include ciprofloxacin, ciprofloxacin-extended release, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, and ofloxacin.

Patients should contact their health care professional immediately if they experience any serious side effects while taking their 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.

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