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| |  IDSA: Achilles Tendon Rupture After Use of Antibiotics By Maury M. Breecher, PhD, MPH SAN DIEGO, CA -- October 17, 2003 -- Case reports and observational studies have suggested an association between fluoroquinolone use and rupture of the Achilles tendon (ATR), according to researchers speaking at the 41st Annual Infectious Disease Society of America held here October 9th to 12th. Epidemiologists, supported by Johnson & Johnson Pharmaceutical Research & Development, sought to define the relative risk of ATR associated with fluroquinolone use and to gather information about that association in a retrospective case-control study. He and fellow investigators used the Ingenix Research Database of claims from 23 health care plans from January 1997 to June 2001. They identified 947 cases of ATR in the 9,832,971 person-years of eligible experience. The researchers developed the crude ATR incidence for this population of 0.96 per 10,000 person years. "Any physician who prescribes fluoroquinolone antibiotics will be happy to be reassured that the occurrence of these ruptures are quite rare, less than one per 10,000 person years [0.96, 95% CI, 0-93 - 1.06]," said John Seeger, DPh, an epidemiologist with Ingenix, Auburndale, Massachusetts. While the study discovered "a very moderate increase" in the rate (OR 1.32) of ATR among patients who had received fluoroquinolones, "The association between exposure to non-fluoroquinolone antibiotics and ATR (odds ratio [OR] = 1.24; 95% CI 1.05 - 1.46) was comparable to that associated with exposure to fluoroquinolones," Dr. Seeger continued. "Antibiotic exposure in the population studied is about 4%," said Dr. Seeger, "and among people getting tendon ruptures it was 5.2%," he said in an interview. The researchers did statistical comparisons on the recency of fluoroquinolone exposure, cumulative dose, and explored interactions such as the concomitant corticosteroid exposure and age, and then looked at the exposure characteristics of the patients taking ofloxacin, levofloxacin, and ciprofloxacin and compared the frequency of those characteristics to other non-fluoroquinolone antibiotics. They then randomly sampled 411 medical records of patients who had ATR claims and compared those findings to the 18,940 randomly sampled case control members of the same health plans and time periods. They found that 49 of the ATR cases had been treated with fluoroquinolones (OR = 1.23, 95% CI 0.90 - 1.68). They calculated that the overall OR for the association between fluoroquinolone exposure and ATR was 1.32. Adjusted for other risk factors the OR for the association was 1.23 (95% CI 0.90 - 1.68). Thus, they concluded, "This association appears to be constant across time in relation to the exposure, and does not appear to be altered with concomitant corticosteroid exposure or age." [Study title: Achilles Tendon Rupture after Use of Antibiotics in a Managed Care Population. Abstract 195]
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