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Fluoroquinolone Antimicrobials (Systemic): Ciprofloxacin, Gemifloxacin, Levofloxacin, Moxifloxacin, Norfloxacin, Ofloxacin

Serious Adverse Reactions including Tendinitis, Tendon Rupture, Peripheral Neuropathy, Central Nervous System Effects and Exacerbation of Myasthenia Gravis

   Tendon Effects, Peripheral Neuropathy and Central Nervous System Effects

  • Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together including:

                      Tendinitis and tendon rupture -  Peripheral neuropathy - Central nervous system effects

  • Discontinue fluoroquinolones immediately and avoid the use of fluoroquinolones in patients who experience any of these serious adverse reactions.
  • Fluoroquinolones may exacerbate muscle weakness in persons with myasthenia gravis.  Avoid fluoroquinolones in patients with known history of myasthenia gravis
  • Because fluoroquinolones have been associated with serious adverse reactions reserve fluoroquinolones for use in patients who have no alternative treatment options for acute bacterial exacerbation of chronic bronchitis.

   Pediatric Use

  • Dosage in Pediatric Patients with Inhalational Anthrax or Plague
    For the recommended LEVAQUIN tablet dosage in pediatric patients with inhalational anthrax or plague. LEVAQUIN Tablets cannot be administered to pediatric patients who weigh less than 30 kg because of the limitations of the available strengths. Alternative formulations of levofloxacin may be considered for pediatric patients who weigh less than 30 kg.

   Risk of Aortic Aneurysm and Dissection

  • Epidemiologic studies report an increased rate of aortic aneurysm and dissection within two months following use of fluoroquinolones, particularly in elderly patients. The cause for the increased risk has not been identified. In patients with a known aortic aneurysm or patients who are at greater risk for aortic aneurysms, reserve fluoroquinolones for use only when there are no alternative antibacterial treatments available.

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

  • Physicians should advise patients, at the first sign of tendon pain, swelling, or inflammation, to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non-fluoroquinolone antimicrobial drug.
  • Selection of a fluoroquinolone for the treatment or prevention of an infection should be limited to those conditions that are proven or strongly suspected to be caused by bacteria.

PATIENT CARE PLAN

FDA and Industry Communications

Medication Guides

Cipro

Proquin XR

Package Inserts

Ciprofloxacin

Gemifloxacin

Levofloxacin

Moxifloxacin

Norfloxacin

Ofloxacin

Additional Information

PubMed - Fluoroquinolone Antimicrobials

Updated June 2020