Cartilage Injury With Levofloxacin Appears Uncommon
In five-year follow-up safety study, no clinically detectable difference for levofloxacin, comparator tx
FRIDAY, June 6, 2014 (HealthDay News) -- Levofloxacin exhibits long-term musculoskeletal safety for children, according to a study published online June 2 in Pediatrics.
John S. Bradley, M.D., of the University of California in San Diego, and colleagues conducted a five-year follow-up safety study involving children who had been treated with levofloxacin or comparator for acute otitis media or community-acquired pneumonia. The presence/absence of cartilage injury was assessed in 2,233 subjects who had persisting musculoskeletal adverse events (MSAEs), protocol-defined musculoskeletal disorders, or were of concern to the Data Safety and Monitoring Committee at one-year follow-up.
The researchers found that 9 percent each of the levofloxacin and comparator subjects who participated in the one-year follow-up study were included in the five-year post-treatment assessment. In both arms, there were an equal number of children with a MSAE during years two to five that were possibly related to drug therapy (one in each group). None of the MSAE cases assessed by the Data Safety and Monitoring Committee at five-year follow-up was likely related to the study drug.
"With no clinically detectable difference between levofloxacin- and comparator-treated children in MSAEs presenting between one and five years in these safety studies, risks of cartilage injury with levofloxacin appear to be uncommon, are clinically undetectable during five years, or are reversible," the authors write.
Several authors disclosed financial ties to Johnson & Johnson/Janssen Research and Development. The study was funded by Janssen, a manufacturer of levofloxacin.