Ciprofloxacin: How is the safety in Children?

Ciprofloxacin, just like other fluoroquinolones, is not recommended for infectious diseases children; due to concern of potential arthropathy and development disturbances risk. All ciprofloxacin labels worldwide list children and adolescent under age of 18 as contraindication of all fluoroquinolones. But how about the experiences?



First, we must know why fluoroquinolones are considered harmful to children's growth. In animal study, cartilage toxicity and arthropathy once found; but the cases were usually species-specific and dose-specific. In pediatric patients, fluoroquinolone is the drug of choice in treatment of pulmonary infections in cystic fibrosis; and is one of treatment choice for genitourinary disorder, Salmonellosis/typhoid fever, severe bacterial infections, and infections in immunocompromised children.

WHO Pocketbook of Hospital Care in Children makes recommendation about ciprofloxacin; that oral dose should be given 10-15 mg/kgBW per dose, 2 times daily, for 5 days. Use in children is only warranted if the benefits outweigh the risk of arthropathy.

As we knew from previous explanation; in children, ciprofloxacin is usually used as treatment of cystic fibrosis pneumonia (acute exacerbation). The daily oral dose given for about 25 mg/kgBW per day. Chysky et al (1991) had conducted study with 634 children, aged 3 days-17 years old; and watch the safety of ciprofloxacin on them. Arthralgia were only reported in 8 cases, all of them were females. But then arthralgia resolved in all of them. Some children then given ciprofloxacin again but shows no signs of arthralgia. They concluded that in this case (i.e. cystic fibrosis pneumonia), ciprofloxacin's safety profile is considered equal to the adults.

The other review by Mitchell (2008) also supported consideration that ciprofloxacin is safe for children. They reviewed seven randomized clinical trials and found out that management of children infections with ciprofloxacin has been still controversial. The benefits including easy administration and its high efficacy (at least as effective as other antibiotics); balanced with physicians' concern about its safety. But their review also showed that noted adverse effects from uses of fluoroquinolones are comparable with other antibiotics, too. The development of arthralgia may be slightly higher with the use of fluoroquinolones than other antimicrobial, but it is usually mild and transient; thus Mitchell considered that the use of fluoroquinolones, especially ciprofloxacin in children; is safe (with the limitation of WHO aforementioned guideline).

But remember that US FDA (United States Food and Drug Administration) has not approved the use of fluoroquinolones in children, due to risk of arthropaty reported by them (about 9.3% per month and 13.6% per year). American Academy of Pediatrics (US) only approved the use of fluoroquinolones in children for the cases of complicated urinary tract infections and pyelonephritis due to Escherichia coli and inhalational anthrax infection. When a child is diagnosed with pneumonia, the use of fluoroquinolones as naive therapy is not recommended.

So here we conclude that even though ciprofloxacin is considered safe for several group of children; the use of this medicine in children should still be restricted until universal safety announcement is released.

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References:
Chysky V, Hullman R, Schacht P et al. Infection 1991; 19 (4): 289-96.
Mitchell R, Cranswick N. International Child Health Review Collaboration, September 2008.
US Food and Drug Administration: Ciprofloxacin-BPCA Pediatric Studies Summary, 2003.