Last reviewed:December 2019
Last updated:July  2019
05 Jul 2019

EMA recommends restricting fluoroquinolone antibiotics to serious or life-threatening bacterial infections only

  • The European Medicines Agency (EMA) has issued an alert recommending that fluoroquinolone antibiotics should not be used for mild to moderate infections unless other appropriate antibiotics for the specific infection cannot be used, and should not be used in non-severe, non-bacterial, or self-limiting infection.[56]

  • This follows a review of adverse effects associated with systemic and inhaled fluoroquinolones, including tendonitis, tendon rupture, arthralgia, neuropathies, and other musculoskeletal or nervous system effects.

  • The UK-based Medicines and Healthcare products Regulatory Agency (MHRA) supports these new restrictions.[61]

  • The Food and Drug Administration (FDA) issued a similar safety communication in 2016, restricting the use of fluoroquinolones in uncomplicated urinary tract infections.[57] In addition to these restrictions, the FDA has issued warnings about the increased risk of aortic dissection, significant hypoglycemia, and mental health adverse effects in patients taking fluoroquinolones.[58][59]

  • As a result of these restrictions fluoroquinolones are no longer recommended in this topic for children with uncomplicated urinary tract infections. Alternative antibiotics, such as a beta-lactam, are suggested instead. However, fluoroquinolone antibiotics are still recommended for children with complicated urinary tract infections.

See Management: approach

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History and exam

Key diagnostic factors

  • fever >102.2°F (39°C)
  • irritability (neonates and infants)
  • poor feeding (neonates and infants)
  • suprapubic tenderness
  • costovertebral angle tenderness

Other diagnostic factors

  • foul-smelling urine (infants, older children, and adolescents)
  • dysuria (preschool age, older children, and adolescents)
  • urinary frequency (older children and adolescents)
  • abdominal/flank pain (infants, older children, and adolescents)
  • vomiting
  • ill appearance (neonates)
  • gross hematuria (older children and adolescents)
  • new-onset urinary incontinence (infants, older children, and adolescents)

Risk factors

  • age <1 year
  • female sex
  • white children
  • uncircumcised boys in the first year of life
  • previous UTI
  • voiding dysfunction (frequency, urgency, withholding maneuvers)
  • constipation
  • vesicoureteral reflux
  • sexual activity
  • no history of breast-feeding
  • obstructive anomalies or previous surgery
  • immunosuppression

Diagnostic investigations

Treatment algorithm


Interim Division Chief

Pediatric Nephrology

The Children's Hospital at Montefiore

Associate Professor of Pediatrics

Albert Einstein College of Medicine




BG declares that she has no competing interests.

Dr Beatrice Goilav would like to gratefully acknowledge Dr Frederick Kaskel, Dr Mary Anne Jackson, and Dr Rene VanDeVoorde, previous contributors to this topic. FK, MAJ, and RV declare that they have no competing interests.

Peer reviewersVIEW ALL

Associate Professor of Pediatrics and Family Medicine

Department of Pediatrics

Hasbro Children's Hospital




RR declares that he has no competing interests.

Professor of Family Medicine and Chairman of the Department of Family Medicine

University of Texas Health Sciences Center




RV declares that he has no competing interests.

Associate Professor

Pediatric Nephrology

Cincinnati Children's Hospital Medical Center




EJ declares that she has no competing interests.

Staff Specialist Paediatrician

Children’s Hospital at Westmead




Not disclosed.

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