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Levofloxacin does not increase children’s risk for musculoskeletal injuries
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No risk differences in musculoskeletal adverse events were seen between children treated with levofloxacin and children treated with comparators, according to new study findings.
In addition, any cartilage injuries that may occur in children treated with levofloxacin appear to become clinically undetectable after 5 years, according to study author John S. Bradley, MD, of the University of California in San Diego, and colleagues.
The researchers followed 207 children, with a median age of 2.9 years, treated with levofloxacin (n=124) or comparators (n=83) 4 years after they completed 1 year of treatment; 9% of each group was included in the follow-up.
Study participants had protocol-defined musculoskeletal disorders or a musculoskeletal adverse event and were considered at high risk for bone or joint toxicity. Of the children included in the 5-year safety assessment, 49% of each treatment group, levofloxacin or comparator, completed the study.
Forty-six children treated with levofloxacin and 16 treated with comparators had protocol-defined musculoskeletal disorders or musculoskeletal adverse events 1 year after completing treatment.
Of those considered to be at the highest risk for a drug-attainable musculoskeletal adverse event, six children reported musculoskeletal adverse events that occurred during years 2 and 5 of observation; three were in the levofloxacin group and three were in the comparator group.
The Data Safety and Monitoring Committee considered 29 children treated with levofloxacin and 10 children treated with comparators to have “possible” drug-attainable protocol-defined musculoskeletal disorders. However, by year 5, only one child had ongoing concerns for possible drug toxicity, according to results of the study
Children in both treatment groups had similar growth characteristics at year 5. Equal percentages of both treatment groups had no change in height percentile, an increase in percentile, and a decrease in percentile.
No serious adverse events were related to the musculoskeletal system.
“The findings of this study should be considered alongside earlier findings of the 12-month [surveillance phase follow-up] study of levofloxacin and provide additional evidence to support the relative safety of levofloxacin in children with respect to cartilage toxicity. If long-term injury occurs with levofloxacin, the rate of these events is low; if injury occurs, it appears to be reversible as assessed at 5 years.
“Careful use of fluoroquinolones for children in situations for which other classes of antibiotics are not available or tolerated, particularly when oral therapy can be used instead of parenteral therapy, is supported by these levofloxacin long term study follow-up data,” the researchers concluded.
Disclosure: Three of the researchers are employees of Johnson & Johnson/Janssen Research and Development.