FDA: Updated Warnings for Antibiotic Class

The association of serious side effects has led to a revision of fluoroquinolone guidelines
The association of serious side effects has led to a revision of fluoroquinolone guidelines

The Food and Drug Administration (FDA) has approved changes to the drug labeling for fluoroquinolone antibacterials for systemic use. This class of drugs has been associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system (CNS) that can simultaneously occur in the patient.  

Currently available fluoroquinolones include: Avelox (moxifloxacin), Cipro (ciprofloxacin), Cipro XR (ciprofloxacin extended-release), Factive (gemifloxacin), Levaquin (levofloxacin), and Ofloxacin.

Fluoroquinolone use should be reserved for patients who have no treatment options for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections because the risks of these serious adverse events generally outweigh the benefits. In cases where the benefits of fluoroquinolones outweigh the risks, it is appropriate for this drug class to remain a treatment option. 

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Patients that experience serious side effects such as unusual joint or tendon pain, muscle weakness, a "pins and needles" tingling or prickling sensation, arm/leg numbness, confusion, and hallucinations, are urged to contact their healthcare provider immediately. These reactions can occur within hours to weeks after initiating fluoroquinolone treatment. 

Healthcare professionals should not prescribe systemic fluoroquinolones to patients who have other therapeutic options for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections due to the risks outweighing the benefits. If a patient experiences serious side effects while taking fluoroquinolones, treatment should be immediately discontinued and switched to a non-fluoroquinolone antibacterial to complete the treatment course. In addition, fluoroquinolones should be avoided in patients who have previously experienced serious fluoroquinolone-associated adverse reactions. 

The FDA has revised the Boxed Warning to address these safety issues and a new warning has been added along with updates to other sections, including the Medication Guide. There is already a Boxed Warning for tendinitis, tendon rupture, and worsening of myasthenia gravis. Other warnings on the labeling include risks of peripheral neuropathy, CNS effects (eg, psychosis, anxiety, insomnia, depression), and cardiac (eg, QT prolongation), dermatologic, and hypersensitivity reactions. The Indications and Usage section now contains a new Limitations of Use statement to reserve fluoroquinolones for patients who do not have other available treatment for the listed conditions. The Medication Guide describes the safety issues associated with these drugs and should be given to the patient with each prescription. 

The FDA had reviewed data from placebo-controlled trials of various antibacterial agents in patients with the aforementioned conditions as well as post-marketing reports of adverse reactions associated with fluoroquinolones. A search of the FAERS database (November 1997–May 2015) found 178 cases of healthy patients who took oral fluoroquinolones for those conditions and developed disabling and potentially irreversible adverse reactions. The majority of the reactions affected the musculoskeletal system, peripheral nervous system, and CNS.

Previously, the FDA had issued safety information related to fluoroquinolones in July 2008, August 2013, and May 2016. The Agency is continuing to evaluate safety issues with fluoroquinolones as part of the ongoing review and will update the public if more data becomes available.

For more information visit FDA.gov.


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