NEW YORK (Reuters Health) – A new analysis finds a very low risk of tendinopathy in adolescents prescribed fluoroquinolone antibiotics.
Fluoroquinolone treatment was associated with an “extremely small” excess risk for tendon rupture and tendinitis compared with alternate antibiotics, “which may not be clinically meaningful,” the study team writes in Pediatrics.
“This analysis provides important context for understanding the risk/benefit ratio of fluoroquinolones for adolescents. Given the rarity of tendon injury and the small excess risks associated with fluoroquinolones, more common adverse drug effects may be more important to consider for treatment decision-making, particularly in adolescents without other risk factors for tendon injury,” write Rachael Ross of the University of North Carolina at Chapel Hill and colleagues.
The findings are based on 4.4 million adolescents with 7.6 million fills for a fluoroquinolone or comparator broad-spectrum antibiotics.
In the 90 days after the antibiotic prescription, there were 842 tendon ruptures and 16,750 tendinitis diagnoses – crude rates of 0.47 and 9.34 per 1,000 person-years, respectively.
There was a small increase in tendon rupture in adolescents prescribed a fluoroquinolone rather than a comparator antibiotic (weighted 90-day tendon rupture risk, 13.6 vs. 11.6 per 100,000), but the excess risk was not statistically significant. If real, this extra risk would mean than 52,632 adolescents would need to be treated with a fluoroquinolone for one additional tendon rupture to occur, the researchers say.
The fluoroquinolone-associated excess risk was statistically significant for tendinitis, but still small (weighted 90-day risk, 200.8 vs. 178.1 per 100,000 for comparator antibiotics), with a number needed to treat to harm of 4,405.
The authors of a linked editorial note that “concerns about fluoroquinolone-associated adverse events (AEs), including tendon injury, have likely resulted in its limited use in pediatrics. However, reports of fluoroquinolone- induced tendon injury are almost exclusively in adults.”
“The strengths of the study include its large sample size of 7.6 million prescriptions evaluated, the comparator group that included other broad-spectrum antibiotics, and the multiple sensitivity analyses and bias analysis performed,” write Dr. Rana El Feghaly and Dr. Jennifer Goldman with Children’s Mercy Kansas City in Missouri.
“Fluoroquinolones are often the only oral option available to treat infections due to multidrug resistant organisms. Data revealing an extremely low risk of tendinopathy in children are reassuring to those prescribing fluoroquinolones to children. However, other side effects reported with fluoroquinolones in adults such as cardiotoxicity, central nervous system AEs, peripheral neuropathy, disorders of glucose homeostasis, hepatic dysfunction, and renal dysfunction still need to be studied in children,” the editorial writers conclude.
The study had no commercial funding and the authors have no relevant disclosures.
SOURCE: https://bit.ly/3bqiNjr Pediatrics, online May 14, 2021.
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