SUMMARY:

In 2013 and 2016, the FDA issued black box warnings on fluoroquinolone antibiotics, recommending limiting use due to rare but severe side effects. Since then, prescription of these antibiotics has significantly decreased. The black box warning remains today. It is recommended to use other antibiotics first for simple bacterial sinusitis, bronchitis, and uncomplicated urinary tract infections (UTI), but fluoroquinolones should still be used when indicated and as a second-line option if no other appropriate antibiotics is available.

Drug Information

• Ciprofloxacin | gemifloxacin | levofloxacin | moxifloxacin | norfloxacin | ofloxacin
• Broad-spectrum antibiotic with gram-negative, gram-positive and some anaerobic activity
• Early fluoroquinolones (e.g. ciprofloxacin) targeted primary gram-negative bacteria, but newer agents have expanded coverage
• Indicated for treatment of UTIs | pneumonia | gastroenteritis | gonococcal infections
• Good oral bioavailability
• Topical use for bacterial keratitis
• Global resistance is increasing
• Avoid giving with calcium supplements, which can decrease their bioavailability
• Common Fluoroquinolone Side Effects:
  • Nausea | vomiting | diarrhea | headache | dizziness | rash
  • QT-prolongation (avoid giving with other QT-prolonging agents)

Rare Serious Fluoroquinolone Side Effects

• Musculoskeletal and Peripheral Nervous System
  • Tendinopathy
  • Tendon rupture (Achilles tendon most common)
    • Concomitant use of corticosteroids can increase risk by as much as 14-fold
  • Joint pain and swelling
  • Peripheral neuropathy
• Cardiovascular
  • Aortic aneurysm and dissection (mixed evidence)
  • QTc prolongation and cardiac arrythmia
• Gastrointestinal
  • Severe diarrhea
  • Taste disturbance
  • Clostridium difficile infection
  • Severe hepatotoxicity
• Other Body Systems
  • Hyper and hypoglycemia
  • Retinal detachment
  • Worsening of myasthenia gravis
• Central Nervous System
  • Agitation
  • Tremor/convulsions
  • Hallucinations/psychosis

KEY POINTS:

• Prescribe fluoroquinolones only when an alternative drug is unavailable
• Recognize patients with risk factors for severe side effects
• Promptly discontinue fluoroquinolones at the first signs or symptoms of any serious adverse reaction (see list above)

Learn More – Primary Sources:

Fluoroquinolone antibiotics and adverse events (2021)

CMAJ: Fluoroquinolone antimicrobial drugs (2017)

Adverse events of fluoroquinolones (2018)

JAMA: Association of Fluoroquinolone Prescribing Rates With Black Box Warnings from the US Food and Drug Administration (2021)

BMJ: FDA Adds “Black Box” Warning Label to Fluoroquinolone Antibiotics (2008)

FDA: CIPRO Medication Guide

Related PcMed Topics:

Sinusitis: From Diagnosis to Treatment

ACP Guidelines: Best Practices for Use of Short-Duration Antibiotics for Common Infections

Uncomplicated Cystitis: When to Culture, How to Treat and Recommended Prevention Strategies