FDA Fluoroquinolone Warning Including Use for UTI Management

SUMMARY:

The FDA has issued warnings and updated drug safety information for oral and injectable fluoroquinolone antibiotics. The FDA recommends

Health care professionals should not prescribe systemic fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risks outweigh the benefits in these patients. Stop 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

Serious Fluoroquinolone Side Effects

Musculoskeletal and Peripheral Nervous System
- Tendinitis
- Anxiety
- Tendon rupture
- Numbness or tingling or pricking sensation “pins and needles” in arms or legs
- Muscle weakness
- Muscle pain
- Joint pain
- Joint swelling

Other Body Systems
- Worsening of myasthenia gravis
- Skin rash
- Sunburn
- Abnormal, rapid or strong heart beat
- Severe diarrhea

Central Nervous System
- Anxiety
- Depression
- Hallucinations
- Suicidal Thoughts
- Confusion

KEY POINTS:

Additional FDA information for healthcare professionals include
- Reserve use of fluoroquinolones for patients with acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and UTI, but no alternative therapies
- Boxed Warning, Warnings and Precautions sections of the labels and revised patient Medication Guide now describe serious risk of multiple disabling and potentially irreversible adverse reactions that can occur together
- Discontinue the fluoroquinolone medicine immediately at the first signs or symptoms of any serious adverse reaction (see list above)

Note: The FDA released a safety announcement (December 2018) regarding increased rare event related to increased risk for aortic rupture or tears