October 21, 2015
Evidence Links Fluoroquinolone Use to Tendon Rupture,
Aortic Issues

Albuquerque, NM—Pharmacists need to be aware of new research on adverse side effects related to use of fluoroquinolones, especially when filling those prescriptions in conjunction with certain other medications.

A recent review led by researchers from the University of New Mexico College of Pharmacy looked at reports from the Food and Drug Adverse Event Reporting System (FAERS) on tendon rupture associated with fluoroquinolone use through September 2012. Their results were published recently in Expert Opinion on Drug Safety.

With 2,495 FAERs reports of tendon rupture related to use of currently approved fluoroquinolones, most, 1,555, were associated with levofloxacin followed by 606 for ciprofloxacin and 230 for moxifloxacin. The mean age of patients developing the condition was 59.6 and, in more than a fifth of the cases, corticosteroids were administered concomitantly with fluoroquinolones (FQ).

“As noted in boxed warnings, FQ use is associated with increased tendon rupture risk,” the researchers write. “Risk factors for FQ associated tendon rupture include use in the elderly, and in patients with concomitant corticosteroids. Further monitoring may be needed due to antibiotic overuse and marketing of newer FQs.”

Another study, published online this month by JAMA Internal Medicine, reviewed the risk of aortic aneurysm and dissection with fluoroquinolone therapy.

“While these were rare events, physicians should be aware of this possible drug safety risk associated with fluoroquinolone therapy,” according to study authors led by researchers from the Department of Emergency Medicine at National Taiwan University Hospital in Taipei.

Background information in the article notes that fluoroquinolones have been associated with collagen degradation. To determine the risk of serious collagen disorders with use of the antibiotics, including aortic aneurysm and dissection, the researchers conducted a nested case-control analysis of 1,477 patients hospitalized for aortic aneurysm or dissection and 147,700 matched controls from Taiwan’s National Health Insurance Research Database (NHIRD) from January 2000 through December 2011.

The study focused on current, past, or any prior-year use of fluoroquinolone, defined as follows:

• Current use was defined as a filled fluoroquinolone prescription within 60 days of the aortic aneurysm or dissection;
• Past use refers to a filled fluoroquinolone prescription between 61 and 365 days prior to the aortic aneurysm; and
• Any prior-year use refers to having a fluoroquinolone prescription filled for three or more days any time during the one-year period before the aortic aneurysm or dissection.

“After propensity score adjustment, current use of fluoroquinolones was found to be associated with increased risk for aortic aneurysm or dissection (rate ratio [RR], 2.43; 95% CI, 1.83-3.22), as was past use, although this risk was attenuated (RR, 1.48; 95% CI, 1.18-1.86),” according to the report.

While sensitivity analysis focusing on aortic aneurysm and dissection requiring surgery also demonstrated an increased risk associated with current fluoroquinolone use, according to study authors, that increase was not statistically significant.

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