Urinary tract infections in children

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. [60] European Medicines Agency. Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics. 19 March 2019 [internet publication]. https://www.ema.europa.eu/en/documents/referral/quinolone-fluoroquinolone-article-31-referral-disabling-potentially-permanent-side-effects-lead_en.pdf

• 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. [55] Medicines and Healthcare products Regulatory Agency. Fluoroquinolone antibiotics: new restrictions and precautions for use due to very rare reports of disabling and potentially long-lasting or irreversible side effects. 21 March 2019 [internet publication]. https://www.gov.uk/drug-safety-update/fluoroquinolone-antibiotics-new-restrictions-and-precautions-for-use-due-to-very-rare-reports-of-disabling-and-potentially-long-lasting-or-irreversible-side-effects

• The US Food and Drug Administration (FDA) issued a similar safety communication in 2016, restricting the use of fluoroquinolones in uncomplicated urinary tract infections. [56] US Food & Drug Administration. FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together. 12 May 2016 [internet publication]. https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-advises-restricting-fluoroquinolone-antibiotic-use-certain 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. [57] US Food & Drug Administration. FDA warns about increased risk of ruptures or tears in the aorta blood vessel with fluoroquinolone antibiotics in certain patients. 20 December 2018 [internet publication]. https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-increased-risk-ruptures-or-tears-aorta-blood-vessel-fluoroquinolone-antibiotics [58] US Food & Drug Administration. FDA reinforces safety information about serious low blood sugar levels and mental health side effects with fluoroquinolone antibiotics; requires label changes. 10 July 2018 [internet publication]. https://www.fda.gov/drugs/drug-safety-and-availability/fda-reinforces-safety-information-about-serious-low-blood-sugar-levels-and-mental-health-side

• 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.

Original source of update