A Commentary on the FDA’s Advice to Avoid Fluoroquinolones for Mild Infections

Pills, Fluoroquinolones
The FDA now advises against choosing fluoroquinolones to treat certain common infections when alternate antibiotics are available.

Fluoroquinolone antibiotics were introduced in clinical practice nearly 25 years ago. Because of their broad spectrum of activity, convenient dosing and generally good tolerability, they have been widely used to treat both serious and mild infections. However, extensive use and post-marketing safety studies have identified an increasingly long list of uncommon but serious adverse effects of these drugs. 

All fluoroquinolones now carry a black box warning regarding the risk of tedinopathy and tendon rupture, peripheral neuropathy, CNS effects, including dizziness, seizures, confusion, hallucinations, depression, and suicidality, and exacerbations of myesthenia gravis. There are additional warnings not cited in the black box for hypersensitivity reactions, hepatotoxicity, Q-T prolongation and arrhythmias, Clostridium difficile infection, and hematologic abnormalities.

As a result, the FDA now advises against choosing fluoroquinolones to treat certain common infections when alternate antibiotics are available. Fluoroquinolones should be avoided for acute sinusitis, exacerbations of chronic bronchitis and uncomplicated urinary tract infections. For these common but general mild conditions, the risk of serious adverse events associated with fluoroquinolone treatment may outweigh the benefits. 

The FDA has not withdrawal approval of use for these indications, but recommends fluoroquinolone use only when no alternate therapy is available. This should be a rare circumstance. The new recommendation to avoid fluoroquinolone treatment also appears within the black box.

Alternates antibiotics for respiratory infections include macrolides (eg azithromycin), ß-lactams (e.g. amoxicillin or amoxillin/clavulanate) and doxycycline. For cystitis, nitrofurantoin or fosfomycin are alternatives. Trimethoprim/sulfmethoxazole or ß-lactams also are effective when susceptibility is confirmed by culture, and for empiric therapy in areas where resistance is infrequent. It should be noted that antibiotics are not routinely recommended as part of initial management of acute sinusitis, which is usually caused by viruses2 and the benefit of antibiotics in acute exacerbations of chronic bronchitis is modest.3

Fluoroquinolones should remain an important treatment option for serious community- and hospital-acquired infections due to susceptible organisms, including pneumonia, skin and soft tissue infections, intra-abdominal infections, bone infections, complicated urinary tract infections, gastrointestinal infections, anthrax, plague and tuberculosis.  Avoiding use in mild infections may also have the added benefit of reducing the spread of resistance, preserving activity of fluoroquinolones in these serious infections.

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1.     FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together. 2016. 

2.     Chow AW, Benninger MS, Brook I, et al. IDSA clinical practice guideline for acute bacterial rhinosinusitis in children and adults. Clin Infect Dis. 2012:e72-e112. doi: 10.1093/cid/cir1043.

3.     Braman SS. Chronic Cough Due to Chronic Bronchitis: ACCP Evidence-Based Clinical Practice Guidelines. Chest. 2006; doi:10.1378/chest.129.1_suppl.104S.